THESIS PROTOCOL

DR. VELLATURU KOUSHIKI

1st YEAR POSTGRADUATE

DEPARTMENT OF GENERAL MEDICINE

KIMS & RF

Dr. YSR UNIVERSITY OF HEALTH SCIENCES VIJAYAWADA

 PROFORMA FOR REGISTRATION OF TOPIC/SUBJECTS FOR DISSERTATION

NAME OF THE CANDIDATE : Dr.VELLATURU KOUSHIKI

ADDRESS : Post graduate in M.D General Medicine,

Konaseema institute of Medical Sciences
Research Foundation, NH-216,
Chaitanya Nagar, Amalapuram, East Godavari
District, Andhra Pradesh.

NAME OF THE INSTITUTION : KONASEEMA INSTITUTE OF MEDICAL

SCIENCES & RESEARCH FOUNDATION
Amalapuram,AP-533201

COURSE OF STUDY AND SUBJECT : MASTER’S DEGREE(MD) IN GENERAL

MEDICINE

DATE OF ADMISSION INTO THE COURSE : 19_10_2023

TITLE OF THE DISSERTATION : “C REACTIVE PROTEIN AND SERUM ALBUMIN

RATIO AS PROGNOSTIC BIO MARKER IN
HOSPITALIZED PATIENTS WITH PNEUMONIA”

BEING SUBMITTED BY COURSE IN : M.D General Medicine

DISSERTATION ON : Significance of C Reactive protein and Serum albumin

ratio in hospitalized patients with Pneumonia
in predicting their prognosis

SIGNATURE OF THE CANDIDATE :

SIGNATURE OF THE PROFESSOR/HOD :

SIGNATURE OF THE GUIDE :

SIGNATURE OF THE PRINCIPAL/DEAN :

 APPLICATION FORMAT FOR INSTITUTIONAL ETHICS
COMMITTEE(IEC)APPROVAL

KONASEEMA INSTITUTE OF MEDICAL SCIENCE & RESEARCH FOUNDATION,

AMALAPURAM

To

The Chairman,

Institutional Ethics Committee (IEC),

KIMS&RF / GH

Amalapuram.

Sub: Review of the Clinical Trial / Material Protocol No........Dated:

Project Title : “C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO

AS PROGNOSTIC BIO MARKER IN HOSPITALIZED
PATIENTS WITH PNEUMONIA”

Department (Place of Study) : Department of GENERAL MEDICINE, KIMS & RF,

Amalapuram.

Principal Investigator Name : Dr. VELLATURU KOUSHIKI

Affiliation : Dr. Y.S.R.U.H.S., Vijayawada, Andhra Pradesh

E-mail : [email protected]

Duration of Study : 2024 -2026 ( 15-18 Months)

Sponsors (if any) :

Approval from any other ethics Regulatory Committee (if required)

Sir,

I hereby submit the above, noted clinical trial protocol for favour of your review and approval. I shall follow
the good clinical practice guidelines and approved protocol in conduction of my research.

Signature of the Signature of the Prof& HOD

Principal Investigator Co-Investigator/Guide Name &Seal

Enclosures:

1. Synopsis of project containing introduction with aim(s) and objectives, review

of literature,justification of study, Methodology describing the potential risk

and benefits, statistical analysis [and whether it is of national significance
(if any) with rationale.]
2. Informed consent form
3. Case record form
4. Study flow chart
5. Sponsor details (if any)
6. Investigator’s brochure
7. Investigator’s undertaking
8. Regulatory permission letter
 FOR IEC OFFICE USE

Proposal: Approved/ Not approved

Date:

Member Member Secretary Chairman

IEC – KIMS&RF IEC – KIMS&RF IEC – KIMS&RF

From

Dr. VELLATURU KOUSHIKI

Dept. of GENERAL MEDICINE
(1st Year PG Student) . .
KIMS & RF, Amalapuram

To,
The Chairman,
Institutional Ethics Committee
KIMS & RF,Amalapuram.

Sir,

I am here with submitting the protocol and plan of the thesis for your kind review and proposal. I shall
follow the good clinical practice guidelines and approved protocol in conducting my research.

Name &Signature of the Guide : DR. PVV SATYANARAYANA, MD GENERAL MEDICINE

Project Title : “C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO

AS PROGNOSTIC BIO MARKER IN HOSPITALIZED
PATIENTS WITH PNEUMONIA”

Department Investigator : Dr. VELLATURU KOUSHIKI

Duration of Study : 2024 to 2026 ( 15 – 18 Months )

Sponsors (if any) :

…………………………………………………………………………………………………………………….
 REGISTRATION OF DISSERTATION

Name of the Student : Dr. VELLATURU KOUSHIKI

Course &Subject : M.D GENERAL MEDICINE

Name of the Medical College : KONASEEMA INSTITUTE OF MEDICAL SCIENCES

AND RESEARCH FOUNDATION

Title of the topic : “C REACTIVE PROTEIN AND SERUM ALBUMIN

RATIO AS PROGNOSTIC BIO MARKER IN
HOSPITALIZED PATIENTS WITH PNEUMONIA”

Name of the Guide : DR. PVV SATYANARAYANA, MD

PROFESSOR
DEPARTMENT OF GENERAL MEDICINE

Date of joining the course : 19-10-2023

Date of commencement
of the course : 06-11-2023

Date of Presentation /
Submission :
 Dr. Y.S.R UNIVERSITY OF HEALTH SCIENCES
VIJAYAWADA, ANDHRA PRADESH

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1. NAME OF THE CANDIDATE &

ADDRESS :Dr. VELLATURU KOUSHIKI,
POST GRADUATE ,
DEPARTMENT OF GENERAL
MEDICINE,
.
KONASEEMA INSTITUTE OF
MEDICAL SCIENCES &
RESEARCH FOUNDATION,
AMALAPURAM,
EAST GODAVARI,
ANDHRA PRADESH.

2. NAME OF THE INSTITUTION :KONASEEMA INSTITUTE OF

MEDICAL SCIENCES &
RESEARCH FOUNDATION,
AMALAPURAM,
EAST GODAVARI,
ANDHRA PRADESH.

3. COURSE OF STUDY & SUBJECT : MASTER DEGREE,GENERAL

MEDICINE
 4. DATE OF ADMISSION INTO THE COURSE : 19_10_20

TITLE OF DISSERTATION “C REACTIVE PROTEIN AND SERUM

ALBUMIN RATIO AS PROGNOSTIC BIO MARKER IN HOSPITALIZED
PATIENTS WITH PNEUMONIA”

INTRODUCTION:

Pneumonia is the most common lower respiratory tract infection and a leading cause
of morbidity and mortality worldwide.1 Pneumonia can result in both respiratory and
non-respiratory complications. The respiratory complications include abscess,
pleurisy, acute respiratory distress syndrome (ARDS), and parapneumonic effusion.
Pneumonia is the most common single cause of ARDS.2 A study published in 1990
stated that approximately 10% of patients who have primary pneumonia that required
ICU admission had ARDS.3
Pneumonia is broadly divided into community-acquired pneumonia or hospital-
acquired pneumonia.

As disease presentation varies from a mild illness that can be managed as an

outpatient to a severe illness requiring treatment in the intensive care unit (ICU),
determining the appropriate level of care is important for improving outcomes in
addition to early diagnosis and appropriate and timely treatment.[4]

CURB 65 (confusion, urea greater than or equal to 20 mg/dL, respiratory rate greater
than or equal to 30/min, blood pressure systolic less than 90 mmHg or diastolic less
than 60 mmHg), and Pneumonia Severity Index (PSI) are tools for severity
assessment to determine the treatment setting, such as outpatient versus inpatient, but
accuracy is limited when used alone or in the absence of effective clinical judgment.
There are restrictions on the usage of the CURB-65 and PSI (Pneumonia Severity
Index). Recent research has discovered that the
biomarkers may provide further information on the severity of CAP, will be able to
differentiate between bacterial and viral etiologies ,and will allow for the early
detection of complications. However, the majority of biomarkers are pricey and
difficult to obtain in an emergency.Within 24 hours of admittance, low serum albumin
levels were independently linked to poor outcomes
Albumin is the most abundant protein in the plasma and has a regulatory role in the
distribution of body fluids, acid-base physiology, and binding of essential components
in the bloodstream. C-reactive protein (CRP) is produced by hepatocytes and is
commonly used to assess inflammation. It was previously noted that acute-phase
concentrations of proteins, such as CRP, tend to rise in inflammatory conditions,
while albumin concentrations tend to decline. Inflammatory biomarkers identified
patients needing intensive care unit admission, including those with delayed intensive
care unit admission.(5)
C-reactive protein-to-albumin ratio (CAR), derived from measurements of CRP and
albumin, has emerged as a novel marker of inflammation and has been used for the
evaluation and monitoring of inflammatory states . It has also been suggested that
serum CAR may be a more reliable risk indicator for inflammatory conditions than
serum CRP or albumin alone.

Albumin is produced in the liver and comprises approximately 60% of serum proteins
. It has a half-life of 19 days ,and plays regulatory roles in acid-base physiology,
binding of essential components in the bloodstream (hormones, fatty acids, bilirubin)
and their transport to organs, inhibition of platelet function, vascular permeability and
in maintaining colloid-osmotic pressure .It also has anti-oxidant activities and free
radical-trapping properties . A large proportion of total serum antioxidant properties
can be attributed to albumin. Hypoalbuminemia in inflammatory conditions is not
uncommon, and it has been suggested that
monocyte products play an important role in reducing albumin production during
inflammation (6)

In parallel, C-reactive protein (CRP) is produced primarily by hepatocytes in the acute

stage of inflammation as a reaction to stimulation by cytokines (such as IL-1, IL-6
and TNF-α) ,Following a conformational change mediated by active platelets, CRP
becomes a pro-inflammatory protein, capable of recruiting additional inflammatory
cells . Its half-life is about 19 h, and its level in the blood rise within 6 h from the
onset of an inflammation or tissue damage. CRP levels peak within 2-3 days from the
onset of inflammation , and rapidly decline with the resolution of the inflammatory
condition. the early elevated serum acute inflammatory biomarkers are cost effective,
feasible for all strata of patients and are noninferior to, NLR, Total WBCs count, IL6,
q-SOFA score and CT scan of chest in predicting mortality of acute pneumonia(7).
Taken together, serum albumin levels are often used as a marker for the presence,
persistence or improvement of a disease , while CRP levels serve as an indicator of
the existence of inflammation . The interactions between albumin and CRP have been
the focus of several recent works. Recently, the CRP/albumin ratio, a combination of
markers for systemic inflammation and nutritional status, has been extensively studied
as an independent prognostic marker in patients with infection, malignancy, and
other .diseases(8). For example, the CRP/albumin ratio (CAR) is now considered a
new biomarker for different clinical conditions . A correlation between this ratio and
the Modified Early Warning Score (MEWS) index was developed for the rapid
identification of critically ill patients .

Within 24 hours of admittance, low serum albumin levels were independently linked
to poor outcomes
The production of cytokines diverts amino acids towards synthesis of acute phase
reactants, thus lowering albumin levels.Serum albumin is a simple, inexpensive,
readily available and indirect biomarker that can be used to determine the severity of
Community acquired pneumonia.
The use of these bio markers to aid in assessing severity of community acquired
pneumonia and stratification accordingly

CRP/albumin ratio is valuable because it is relatively simple and easy to use in all
settings.
AIM OF THE STUDY

To determine the role of Serum C Reactive protein (CRP)/Albumin ratio in predicting

prognosis in Hospitalized patients with pneumonia .

OBJECTIVES OF THE STUDY

To determine the role of Serum CRP/Albumin ratio in predicting the prognosis in
Hospitalized patients with Pneumonia
Use of Serum CRP /Albumin ratio in risk stratification of patients
Find out the corelation of Serum CRP /Albumin ratio to CURB 65 scoring.
Early identification of pneumonia patients who are at risk for complications with the
aid of serum CRP /Albumin ratio

REVIEW OF LITERATURE:

Albumin and CRP were associated with 28-day mortality in hospitalized patients with
CAP, and these markers have increased the prognostic performance when combined
with the PSI scale.(9)
A retrospective study of 123 patients with AIDS related PCP admitted at Beijing Di-
Tan Hospital concluded that combining CAR >2.0 mg/g enhanced the capability of
CURB-65, APACHE II, and PSI in predicting the 180-day mortality of patients with
AIDS-related PCP.(10)
The CRP/albumin ratio has been extensively studied as an independent prognostic
marker in patients with infection, malignancy, and other diseases [11,12]. Kim et al.
reported that the CRP/albumin ratio at admission was positively correlated with
prognosis
In a study of elderly patients admitted via the emergency room, high-sensitivity-
CRP/albumin ratio at admission to the emergency department was associated with all-
cause in-hospital mortality among patients older than 65 years (13)

In a single centre study with a retrospective data base of 548 patients aged 18 -97 with
COVID 19 pneumonia Hospitalized at the Istanbul Kanuni Sultan Süleyman Training
and Research Hospital from March 21 to April 30, 2020 it was concluded that C-
reactive protein to albumin ratio was the best inflammatory predictor compared with
other indexes for the early identification of severe coronavirus disease 2019
pneumonia, CAR is higher in patients in the severe group compared with patients in
the nonsevere group(14)

In a retrospective study done on 272 patients over the age of 18 years hospitalized in
the internal diseases COVID-19 ward of İzmir Katip Celebi University Ataturk
Training and Research Hospital who were diagnosed with SARS-CoV-2 infection
with a positive RT-PCR test , the clinical, laboratory, and radiological findings were
analysed ,the results of the study revealed that CAR is a potential parameter in
distinguishing critically ill COVID-19 patients in need of intensive care.(15)

In a retrospective study conducted on 296 patients with Covid 19 pneumonia, C-

reactive protein/albumin ratio was statistically significant for the risk of intensive care
admission(16)

C-reactive protein and albumin were measured in serum samples at baseline from
2489 men aged 42-61 years, from the Kuopio Ischemic Heart Disease study. It was
concluded in their study that In middle-aged and older Finnish men, elevated serum
CAR and CRP levels were each associated with an increased risk of pneumonia.
Further research is needed to replicate these findings in other populations and-assess
the potential value of CAR in the prevention and management of pneumonia.(17)

Additional clinical indicators of severe disease, such as bilateral or multilobar

consolidation ;acidosis ,positive blood cultures, hypoalbuminaemia and hypoxia,
when used supports risk stratification by CURB-65 (18)]. Many biomarkers have
also been tested for their use in improving risk stratification of patients with CAP,
including C-reactive protein (CRP), pro-calcitonin (PCT), cytokines and several stress
hormones (19) Of these, CRP and albumin are the most readily available do provide
additional data that aids in evaluation of prognosis.

Both albumin and CRP are acute phase reactant proteins. C-reactive protein (CRP) is
synthesized by hepatocytes in response to infection or tissue inflammation (20-22)
Decreased albumin levels during acute infection are also directly caused by the
underlying inflammation process, provide an illustration of the severity of
infection/inflammation (23-24)

In a study conducted by Viasus D et al [25] investigated, whether serum albumin levels

within 24hr of admission decreased with outcomes in community-acquired
pneumonia (CAP) showed levels of serum albumin decreased, and the risk of
complications significantly increased (P <.001). Decreased albumin levels were also
associated with prolonged time to reach clinical stability (P <.001), prolonged hospital
stay (P <.001), ICU admission (P <.001), the need for mechanical ventilation (P
<.001) and 30-day mortality (P <.001).

In a study by Lee et al [26], it got reported that albumin was associated with 28-day
mortality in patients hospitalized with a CAP diagnosis.
Akpinar E E et al in a prospective observational study in 216 CAP patients, has also
shown that low albumin level was an independent marker for development of
complications and need for ICU.
There are various studies showing an association of CRP and albumin levels in
assessing the severity of CAP. In levels conducted by Chalmers JD et al [27,28]
showed a CRP of <100 mg/l is independently associated with a lower mortality
increased 9.6 and >100 mg/l with increased risk of complication by CAP and also
raised CRP level was associated with increase complication development Para
pneumonic effusion and empyma thoracis.

A study by lokendra dave et al [29] showed the trend that patients with CAP have low
levels of serum albumin (mean value 2.91+_0.09 gm/dl) and this value decreases
significantly with increasing severity of pneumonia (p<0.001). In pneumonia cases,
serum albumin shows a decreasing trend along with increasing severity of disease
with statistically significant (p<0.001) difference in mean serum albumin level in all
three CAP groups with different levels of severity.

A study by Latha V. et al concluded that patients with severe hypoalbuminemia had

high morbidity and mortality in the form of ICU requirements and a need for
mechanical ventilation,it was also concluded in their study that CRP serves as an
important marker of inflammation whose series levels reduce significantly with
cure /resolution of pneumonia (30)

A prospective cohort study conducted on 180 subjects of acute pneumonia, who were
admitted in icu at KR hospital, Mysuru from February 2021 to October 2022. Which
proved that, there is a irrefutable positive association between early elevated serum
acute inflammatory biomarkers, Total WBCs count, NLR, IL6 level, q- SOFA score
and chest CT severity score with that of mortality in acute pneumonia.It was
concluded in their study that serum acute inflammatory biomarkers are significantly
raised, as in comparison with the Total WBCs count, NLR, IL6 level, q- SOFA score
and positive CT chest findings in acute pneumonia;So the early elevated serum acute
inflammatory biomarkers are cost effective, feasible for all strata of patients and are
noninferior to, NLR, Total WBCs count, IL6, q-SOFA score and CT scan of chest in
predicting mortality of acute pneumonia.(31)

A prospective study by Huasong Lu et al that included 35 patients attending hospital

with community acquired pneumonia was conducted which concluded CRP, cortisol,
and HMGB-1 levels were all significantly higher in patients who died compared with
survivors.(32)
 METHODOLOGY

STUDY DESIGN : This is a prospective study

STUDY POPULATION : Hospitalized patients with pneumonia

SAMPLE SIZE : As per a prospective cohort study conducted on subjects of

pneumonia, admitted in at KR hospital, Mysuru ,Standard deviation of C reactive
protein levels is +/-3.4mg/l

Using the formula

N= (Z2 SD2 ) /( L2)

N = sample size

Z=Z score (taken as 1.96 for confidence interval of 1.96)

SD=Standard deviation

L=allowable error (taken as 1 here)

N=(1.96x1.96x3.4x3.4)/1x1

N=44

So we will include 50 subjects in the current study

 SAMPLE SITE : This study will be conducted in
Konaseema Institute of Medical
Sciences & Research Foundation
located in ,
Amalapuram, East Godavari Dist. Of
Andhra Pradesh.

STUDY PERIOD : Proposed to complete the study in

stipulated period from 2024 To 2026
(15-18 Months )

SAMPLING TECHNIQUES : Simple random sampling

SELECTION CRITERIA

Having informed consent for participation from the patient and/or patient
party,the patient will
be included in the study according to the following criteria-

INCLUSION CRITERIA:

 Patients of Age >18years of both genders

 Patients hospitalized with Community Acquired Pneumonia

EXCLUSION CRITERIA:

 Patients with age<18years

 Burns
 Patients with liver disease
 Patients with malabsorption syndromes
 Patients with autoimmune disorders
 Patients with pre-existing renal disease
 Diabetics
 Pregnancy and lactation

Data collection: Hospitalized patients with pneumonia based on the study inclusion
and exclusion criteria will be selected and explained about the study and enrolled after
giving informed consent
 Ethical issues:
1. Study will be started after seeking approval from Institutional Ethical Committee of
KIMS and RF .
2. Written and Informed consent will be taken from all the subjects.

METHODOLOGY :
After prior institutional ethical clearance and obtaining informed consent,the
participants satisfying inclusion criteria were asked detailed history and clinical
examination will be performed according to the well designed preforms cited
below .Serum CRP and albumin levels will be measured by venous blood sample and
it’s corelation with CURB 65 will be assessed.

STATISTICAL ANALYSIS:
The collected data will be entered in MS Excel spreadsheet. Data will be analyzed
using the statistical software SPSS for Windows, latest version.
 STUDY CONSENT FORM

I __________________________________,age_____, sex_______ ,exercising my

free power of choice, hereby give my consent for participating as a subject in the
study entitled

“C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO AS

PROGNOSTIC BIO MARKER IN HOSPITALIZED PATIENTS
WITH PNEUMONIA”
I have been explained to my satisfaction about the nature of the study. I am also aware
of my right to opt out of the trail at any time during its course without having to give
reasons for doing so. All these things have been explained in the language known to
me.

Date:

Signature of participant:

Location:
 Investigator’s Undertaking
I Certify that the information provided by me is complete and
correct.

I understand that as principal investigator, I will take full

responsibility for the protection of rights and welfare of all trial
subjects including the conduct of study and ethical performance
of the project.

I agree to comply will all rules and regulations of IEC and

Konaseema Institute of Medical Sciences & Research
Foundation, Amalapuram of the conduct of trail.

I hereby declare, Qualified personnel according to IEC will

conduct the study. No change will be made in the protocol or
consent form until approved by the IEC. Legally effective
informed consent will be taken from Human subjects if
applicable. Adverse events will be reported to IEC as per ICH
GCP/DCGI adverse event reporting policy

I further certify that the proposed research is not currently being conducted
and will not begin until IEC approval has been obtained.

The Investigators Signature Date

Principal Investigator

Institutional Ethics Committee of Medical College &

Hospital, met
on _at
scrutinize the Synopsis/Research projects of Postgraduate students /
undergraduate students/Faculty members of this College from Ethics
point of view.

After scrutiny, the following version of Synopsis of

dissertation /Research project has been accorded Ethics
Clearance.

TITLE: “C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO AS

PROGNOSTIC BIO MARKER IN HOSPITALIZED PATIENTS WITH
PNEUMONIA”
 INFORMED CONSENT

I have read and understood the information it has been read over to me and
explained to me in an understandable language about the research project: “C REACTIVE
PROTEIN AND SERUM ALBUMIN RATIO AS PROGNOSTIC BIO MARKER IN
HOSPITALIZED PATIENTS WITH PNEUMONIA” I have had the opportunity to ask
questions about it and questions that I have asked have been answered to my satisfaction. I
consent voluntarily to participate as a participant in this research.

Name of Participant…………………………………………..
Signature of Participant………………………………….
Date………………………………………………………………
Day/month/year
If illiterate:
I have witnessed the accurate reading of the consent form to the potential participant and the
individual has had the opportunity to ask questions which have been properly answered by the
Researcher in my presence. I confirm that the individual has agreed to participate in the
research and has given consent freely.
Name of witness……………………………………………………….. AND Thumb print of
participant
Signature of
witness……………………………………………………

Date …………………………………………………….
Day/month/year
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant and to the best of
my ability made sure that the participant has understood the procedures to be gone through:
I confirm that the participant was given an opportunity to ask questions about the study and I
have answered all questions asked by the participant correctly and to the best of my ability. I
confirm that the individual has not been coerced into giving consent and that the consent has
been given freely and voluntarily.
A copy of this ICF has been provided to the participant.
Name of Researcher/person taking the consent: Dr.VELLATURU KOUSHIKI
 సమాచార మరియు వినతి పత్రము
ఒక పరిశోధనాధ్యాయములో పాల్గొనమని మిమ్మల్ని ఇందుమూలముగా ఆహ్వానించడము జరుగుతున్నది. ఈ
అధ్యయనము కిమ్స్ మెడికల్ కాలేజీ జనరల్ మెడిసిన్ విభాగం ద్వారా జరుపబడుతున్నది. ఈ అధ్యయనంలో
పాల్గొనాలా లేదా అని మీరు నిర్ణయించుకోవడానికి ఈ అధ్యయనంలో మీ పాత్ర గురించి తెలుసుకోవడం ముఖ్యం.
కాబట్టి, ఈ సమాచారాన్ని జాగ్రత్తగా చదవండి

పరిశోధన పేరు : " కమ్యూనిటీ న్యుమోనియాతో ఆసుపత్రిలో చేరిన రోగులలో ప్రోగ్నోస్టిక్ బయోమార్కర్లు గా సి
రియాక్టివ్ ప్రోటీన్ మరియు సీరమ్ ఆల్బుమిన్ స్థా యిలు”అధ్యయనం

పరిశోధకురాలు పేరు: వెల్లటూరు కౌషికి, పి.జి (జనరల్ మెడిసిన్), కిమ్స్ ఆసుపత్రి, అమలాపురం.

ఈ పరిశోధనాధ్యాయములో మీ జీవన శైలి నాణ్యత గురించి, విద్య, వృత్తి, నివాస, ప్రాంతీయ, వైవాహిక, కుటుంబ
సభ్యుల వివరాలు మరియు ఆరోగ్య సమస్యలు రోగి మునుపటి ఆరోగ్య వివరములు తెలుసుకుంటాం

ఈ శాస్త్రీయ అధ్యయనములో పాల్గొన్న వారి పేరు మరియు వ్యక్తిగత వివరాలు గోప్యంగా ఉంచబడుతాయి.. ఇందులో
పాల్గొనందు వల్ల మీకు ఎటువంటి హాని కలగదు. మీ సమాచారం వైద్యశాస్త్ర ప్రగతికి ఉపయోగపడుతుంది. ఈ
అధ్యయన వివరాలు ఏదైనా సదస్సుకుగాని, ప్రచురణకుగాని ఎంపికైన ఎడల మీ అనుమతిని కోరుతున్నాము.

అధ్యయనంలో మీ భాగస్వామ్యం స్వచ్ఛందంగా ఉంటుందని మరియు ఎటువంటి కారణం చెప్పకుండా, మీ వైద్య

సంరక్షణ లేదా చట్టపరమైన హక్కులు అమలులోకి రాకుండా మీరు ఎప్పుడైనా ఉపసంహరించుకోవచ్చు.

మీకు తెలుగు చదవడం రానిపక్షమున మీకు తెలుగులో పూర్తిగా చదివి వినిపించి మీరు అర్ధం చేసుకున్న తర్వాత మీరు
పూర్తిగా ఆలోచించుకుని మీ సంతకం చేయమని కోరుతున్నాము.
 అధ్యయన సమ్మతి పత్రము

-----------------------పేరుగల నేను, వయస్సు ----------- .... నాకు పైన చెప్పబడిన అధ్యయన వివరములను
చదివి లేదా విని అర్ధం చేసుకొని స్వచ్ఛందంగా ఈ అధ్యయనములో పాలుపంచుకొంటున్నట్లు గా నా ఈ క్రింది
సంతకం ద్వారా ధృవపరుస్తు న్నాను.

సంతకం/ఎడమ బొటనవేలు ముద్ర : ముఖ్య పరిశోధకుని సంతకం

తేదీ : స్థలము :
INVESTIGATIONS:
INVESTIGATIONS THAT WILL BE SENT FOR ALL PATIENTS
1.Complete Blood Count
2.Renal Function Test
3.C reactive protein
4.Liver Function Test
5.Serum Electrolytes
6.ECG
7.X ray Chest
8.Random blood sugar

STATISTICAL ANALYSIS
Descriptive and inferential statistical analysis to be carried out in the present study. Results on
continuous measurements will be presented in mean SD (Min-Max) and results on categorical
measurements will be presented in number (%). Significance will be assessed at 5 % level of
significance. The Chi-square/ Fisher Exact test will be used to find the significance of study
parameters

CASE RECORD FORM

NAME :
AGE/SEX:
 Case NO:
IP No:
OCCUPATION:
DOA:
DOD:
ADDRESS:

PRESENTING COMPLAINTS:

Breathlessness
Oliguria
Abdominal pain/ vomiting
Swelling of limbs
Chest pain
Altered sensorium
Cough
palpitations
Others
Easy fatigue ability

PAST HISTORY:
Treatment details:

MEDICAL HISTORY:
Hypertension
Diabetes
Smoker/
Alcoholic
History of
CAD

CLINICAL
EXAMINATION:
Built
Nourishment
Pallor Icterus Cyanosis Clubbing Pedal edema Lymphadenopathy
Vitals-
BP:
MAP:
Spo2:
Respiratory Rate:

SPO2:
Height : Pulse rate :

System Examination:
Respiratory System:

Inspection:

• Position of Trachea
• Any Chest of spine deformities
• Chest expansion • Any engorged veins on chest
•
• Palpation:
•
• Tracheal position
• Respiratory movements
• Any Tenderness • Vocal Fremitus
•
• Percussion:
•
• Percussion in all areas
•
• Auscultation:
•
• Type of Breath sounds
• Vocal Resonance
• Any added sounds
Cardiovascular system:
Inspection:
• Position of trachea Position of Apex beat Other Pulsations
• Dilated and engorged veins on chest
• JVP
Palpation:
• Palpation of Apical impulse : site & nature
• Position of Trachea
• Any Tenderness
• Thrills
• Parasternal Heave
Percussion:
• Percussion of heart borders
Auscultation:
• Mitral Area:
• Tricuspid area:
• Pulmonary area:
• Aortic area:
Inspection:
• Shape of abdomen
• Any swellings
• Engorged veins on abdomen

Palpation:
• Any Tenderness
 • Organomegaly
• Rigidity

Percussion:
• Shifting dullness
• Liver span

Auscultation:
• Bowel sounds
• Any Bruits

Central Nervous System:

• Higher functions
• Cranial nerves
• Motor system
• Sensory system
• Reflexes
• Signs of cerebellar involvement
• Signs of meningeal irritation

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Pulm Respir Med 2013; 3(5):1000159.

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for pneumonia: Findings from a prospective cohort study. Respir Med. 2022 Aug;199:106894. doi:
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26. Lee JH, Kim J, Kim K, Jo YH, Rhee J, Kim TY, Na SH, Hwang SS. Albumin and C-reactive protein
have prognostic significance in patients with community-acquired pneumonia. J Crit Care. 2011
Jun;26(3):287-94. doi: 10.1016/j.jcrc.2010.10.007. Epub 2010 Dec 3. PMID: 21129911.

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for pneumonia: Findings from a prospective cohort study. Respir Med. 2022 Aug;199:106894. doi:
10.1016/j.rmed.2022.106894. Epub 2022 May 29. PMID: 35659744.

32. Hui Wang, Yufei Chang, Zhi-Zhang Cui, Zhi-Juan Liu, and Shan-Fang Ma.Admission C-Reactive
Protein-to-Albumin Ratio Predicts the 180-Day Mortality of AIDS-Related Pneumocystis
Pneumonia.AIDS Research and Human Retroviruses.Sep 2020.753-
761.http://doi.org/10.1089/aid.2020.0057
 HAVE YOU OBTAINED ETHICAL CLEARANCE FROM THE INSTITUTIONAL
ETHICS COMMITTEE? –

SIGNATURE OF THE CANDIDATE:

NAME AND DESIGNATION

OF THE GUIDE : DR.PVV SATYANARAYANA,
M.D. GENERAL MEDICINE

PROFESSOR in GENERAL
MEDICINE.

SIGNATURE OF THE DEAN :

DR. K. SIVA PRASAD, MD NAME OF THE GUIDE:

PROFESSOR AND HOD DR. PVV SATYANARAYANA, MD
GENERAL MEDICINE GENERAL MEDICINE
 CASE RECORD FORM

PARTICULARS OF THE PATIENT

Name: OP/IP No.

Age:

Sex:

Religion:

Social Status:

Occupation:

Chief complaints:

Fever:Yes/No Duration: days Chills: Yes/No

Sore throat: Yes /No Duration: days

Cough: Yes/ No Duration: days Sputum: Yes/No Colour:

Rhinorrhea: Yes /No Duration: days

Breathlessness: Yes/ No Duration: days

Diarrhoea: Yes /No

Vomiting: Yes /No

Anosmia: Yes /No Duration: days

Ageusia: Yes /No Duration: days

Malaise Yes/No

Myalgia Yes/No

Any travel history :Yes/ No

Comorbidities:

Hypertension Yes / No Diabetes Yes / No

Chronic lung disease Yes / No Cardiac failure Yes / No

Malignancy Yes / No PTCA/CABG Yes / No

IMMUNESUPRRESSIVE MEDICATION : Yes/No

Risk Factors For Severe Disease : Yes/No

Current medications if any :

1.

2.

3.

4.

Smoking Never smoked /Current smoker/ Ex-smoker / Stopped yrs ago

Cigarettes per day: No. of years of smoking: Pack years:

Alcohol consumption :Never / Current drinker / Ex-drinker / No of years

of abstinence: Type of alcohol consumed:

Amount consumed on a typical drinking day:

Frequency of drinking in a month 1-2 3-4 5-6 7-9 10+

Allergies/Intolerances to any drug if any :

Examination

RR: SpO2: Temp : Weight

HR: BP: Height:

Orientation:Time Place Person

CURB 65:
GCS: Eyes /4 Verbal /5 Motor /6 Total

/15

Pallor + - Icterus + - Cyanosis + - Clubbing +

- Lymphadenopathy+- Pedaloedema +
-

Other relevant general exam findings

CVS

Abdomen

RS

CNS
 Clinical differential diagnoses for the presenting:
1.

2.

3.

Other coexisting problems :

*Severity Category:

*Investigations:CRP

SERUM ALBUMIN
 PROTOCOL

Amalapuram,
Date:
From,
Dr. K SIVA PRASAD
Professor & H.O.D,
Department of General Medicine,
Konaseema Institute of Medical Sciences and Research Foundation,
Amalapuram.

To,
The Registrar,
Dr.N.T.R.U.H.S,
Vijayawada.
// Through proper channel //

The Dean,

Konaseema Institute of Medical Sciences and Research Foundation,

Amalapuram.

Respected sir,

Sub :- Thesis/ Dissertation of Dr. VELLATURU KOUSHIKI year Post Graduate Student
in M.D General Medicine(2024 _2026), Konaseema Institute of Medical Sciences
and Research Foundation protocol submission – regarding.

Here with I am forwarding the following protocol regarding the Post Graduate student
Thesis/Dissertation of 1st year student, VELLATURU KOUSHIKI General Medicine
admitted in the course for the year( 2023-2026)

TITLE OF THE TOPIC : : “C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO

AS PROGNOSTIC BIO MARKER IN HOSPITALIZED
PATIENTS WITH PNEUMONIA”

AIM OF THE STUDY

To determine the role of Serum C Reactive protein (CRP)/Albumin ratio in predicting prognosis
in Hospitalized patients with pneumonia .
OBJECTIVES OF THE STUDY
1.To determine the role of Serum CRP/Albumin ratio in predicting the prognosis in
Hospitalized patients with Pneumonia
2.Use of Serum CRP /Albumin ratio in risk stratification of patients
3.Find out the corelation of Serum CRP /Albumin ratio to CURB 65 scoring.
4.Early identification of pneumonia patients who are at risk for complications with the aid of
serum CRP /Albumin ratio

DURATION OF THE STUDY : Proposed to complete the study in a period

between 2024 to 2026 (15-18 Months )

It is proposed that Dr.VELLATURU KOUSHIKI Post Graduate student in M.D, General

Medicine will carry out this work under the guidance of Dr. PVV SATYANARAYANA
MD, Professor, Dept. of General Medicine.

I request you to kindly accept the above proposal positively.

Thanking you Sir,

Your’s sincerely,

DR.K SIVAPRASAD M.D,

Professor and H.O.D,

Dept. of General Medicine,

KIMS & RF
 Amalapuram,
Date :

From

Dr. PVV SATYANARAYANA M.D,

Professor,
Dept. of GENERAL MEDICINE,
Konaseema Institute Of Medical Sciences & Research
Foundation, Amalapuram.

To

The Dean,

Konaseema Institute of Medical Sciences & Research Foundation,

Amalapuram.

Sub : Allotment of thesis topic to the Post Graduate student in M.D, GENERAL
MEDICINE.

Sir,

This is to inform that the following topic is allotted to the 1st year Post Graduate
student in M.D, GENERAL MEDICINE. “C REACTIVE PROTEIN AND
SERUM ALBUMIN RATIO AS PROGNOSTIC BIO MARKER IN
HOSPITALIZED PATIENTS WITH PNEUMONIA”
1styear Post Graduate student in M.D GENERAL MEDICINE,(2024-2026). She has
to submit the protocol of the dissertation to the ethical committee of the college for their
approval and for onward transmission to the Dr.
N. T. R. University of Health Sciences for acceptance.
I will guide the post graduate student in conducting the research project.

Thanking you
Yours sincerely,
Dr. PVV SATYANARAYANA., M.D PROFESSOR
DEPARTMENT OF GENERAL MEDICINE
KIMS & RF.
 Amalapuram,
Date:
From
Dr.VELLATURU KOUSHIKI,
1st year Post Graduate,
M.D. GENERAL MEDICINE,
KIMS & RF,
Amalapuram.

To

The Dean, KIMS

& RF
Amalapuram.

//Through Proper channel//

Respected Sir,

Sub : Post Graduate Medical education – Dr.VELLATURU KOUSHIKI, Post Graduate

in M.D(GENERAL MEDICINE ), KIMS & RF, submission of dissertation protocol.

I Dr.VELLATURU KOUSHIKI, joined as Post graduate in M.D(General

Medicine) on 19-10-2023 in KIMS & RF, Amalapuram.
I am working under the guidance of Dr. PVV SATYANARAYANA M.D,
Department of GENERAL MEDICINE, KIMS & RF, Amalapuram. I am allotted
the dissertation : “C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO
AS PROGNOSTIC BIO MARKER IN HOSPITALIZED PATIENTS WITH
PNEUMONIA”

I am here with submitting the protocol and plan of the thesis for your kind perusal
and necessary action.

Thanking you,

Yours sincerely
Dr.VELLATURU KOUSHIKI

1ST Year POST GRADUATE,

M.D. GENERAL MEDICINE.
 Amalapuram,
Date:

From

Dr.VELLATURU KOUSHIKI,
Post graduate in M.D GENERAL MEDICINE,
KIMS & RF,
Amalapuram.

To

The Chairman,
KIMS Ethics committee, KIMS
& RF,
Amalapuram.
Sir,

I am here with submitting the protocol and plan of the thesis for your kind review and
proposal. I shall follow good clinical practice guidelines and approved protocol in conducting
my research.

PROJECT TITLE :

:
“C REACTIVE PROTEIN AND SERUM ALBUMIN RATIO AS
PROGNOSTIC BIO MARKER IN HOSPITALIZED PATIENTS WITH
PNEUMONIA”
DEPARTMENT : M.D GENERAL MEDICINE

INVESTIGATOR : Dr . VELLATURU KOUSHIKI

EMAIL : [email protected]

DURATION OF STUDY : 2024 to 2026 (15-18 Months)

GUIDE : DR. PVV SATYANARAYANA,M.D.

SPONSORS : NIL

Signature of the investigator Signature of the Guide

 Amalapuram,
Date:
From

Dr.VELLATURU KOUSHIKI
1st year Post Graduate,
M.D GENERAL MEDICINE,
Konaseema Institute Of Medical Sciences & Research Foundation,
Amalapuram.

To

The Registrar,

Dr.Y.S.R.U.H.S,
Vijayawada.
//Through proper channel//

Sub :- Submission of dissertation topic to the Dr.Y.S.R.U.H.S, for registration and

allotment of number-Regarding.

Sir,

I Dr.VELLATURU KOUSHIKI, 1st Year Post Graduate student in M.D ,(2023-2026)

submitting my Thesis/Dissertation topic.
My topic is: “C REACTIVE PROTEIN AND SERUM
ALBUMIN RATIO AS PROGNOSTIC BIO
MARKER IN HOSPITALIZED PATIENTS WITH
PNEUMONIA”

Kindly register my topic, and allot me a registration number.

Thanking you,
Yours sincerely,
DR. VELLATURU KOUSHIKI
1ST year Post graduate,
Dept. of GENERAL MEDICINE.