RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE

ANNEXURE – IIPROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1Name of the candidate and address ( in block letters)

:

DR. DYANESHWAR NIRGUDE

Post graduate student

Department of medicine

Bangalore medical collage &

Research institution

Bangalore - 560001

2 Name of the institution :

Bangalore Medical Collage &

Research Institution, Bangalore,

Fort Area K R Road, Bangalore – 560002

3Course of study and subjects

: M.D. (General Medicine)

4Date of admission to the course

: 01-07-2015

5 Title of Topic :

STUDY OF NEUTROPHIL LYMPHOCYTE COUNT RATIO

IN COMMUNITY ACQUIRED PNEUMONIA PATIENTS AS

A PROGNOSTIC INDICATOR AT TERTIARY CARE

CENTRE.

1

6 Brief Resume of the intended work

6.1 Need for the study

Community-acquired pneumonia (CAP) is a common, potentially fatal disease despite

advances in both diagnosis and treatment1.Although new techniques are being developed,

defining the microbial etiology and classifying the severity of Community Acquired

Pneumonia (CAP) both remain challenging issues. Biomarkers, preferably in combination

with clinical risk scores, are increasingly used to identify specific patients at risk, to judge

the severity of illness and prognosis of Community Acquired Pneumonia (CAP) and more

recently to guide antibiotic therapy2. As the allocation of resources is, however, important,

the high prices for the use of newly developed biomarkers make their use less attractive3.

Immuno-competent white blood cell populations play an important role in the systemic

inflammatory response to infection. Following endotoxemia the number of circulating

neutrophils increases while lymphocyte counts decrease4. Recently, the latter showed its

potential in predicting bacteremia or the severity of several infectious diseases5. Initially,

this so-called Neutrophil-Lymphocyte Count Ratio (NLCR) was studied as an infection

marker in ICU patients and found to correlate well with disease severity and outcome,

according to APACHE-II and SOFA scores6, In a retrospective study, the Neutrophil-

Lymphocyte Count Ratio (NLCR) proved to be a simple and even better marker in

predicting bacteremia than routine parameters, like white blood cell (WBC) count and C-

reactive protein (CRP) level, in infectious emergency admissions7.Other studies focused

on the use of the Neutrophil-Lymphocyte Count Ratio (NLCR) in specific clinical

conditions, like appendicitis, or its use as an independent predictor of survival in patients

with various conditions ranging from oncological to cardiovascular diseases8. As

Community Acquired Pneumonia (CAP) is an important reason for Emergency

Department (ED) admission and subsequent hospitalization, we prospectively study the

prognostic value of Neutrophil-Lymphocyte Count Ratio (NLCR) in Community

Acquired Pneumonia (CAP) patient.

6.2

Review of Literature

2

A study by de Jager CP1 et al 2007 showed that. Admission Neutrophil-Lymphocyte Count Ratio (NLCR) at emergency department predicts severity and outcome of Community Acquired Pneumonia (CAP) with a higher prognostic accuracy as compared with traditional infection markers 9.

A study by Ateş H1, 2013 et al study showed that. Because of similar clinical manifestations and laboratory findings, differential diagnosis of pulmonary embolism and community-acquired pneumonia (CAP) is generally difficult. Therefore, this study was conducted to find good markers for the easy, cheap, and fast differential diagnosis of pulmonary embolism and Community Acquired Pneumonia (CAP) . First day neutrophil count (P = 0.005), NLR (P = 0.002), CRP (P < 0.001), erythrocyte sedimentation rate (P < 0.001), PCT (P < 0.001), NLR/D-dimer (P < 0.001), and PCT/D-dimer (P < 0.001) levels were higher in patients with Community Acquired Pneumonia (CAP) compared with patients with pulmonary embolism10.

A study by Yoon NB1, 2010et al showed that. Serum NLR levels were significantly lowers in patients with pulmonary TB than in patients with bacterial Community Acquired Pneumonia (CAP) . The NLR obtained at the initial diagnostic stage is a useful laboratory marker to discriminate patients with pulmonary TB from patients with bacterial Community Acquired Pneumonia (CAP) in an intermediate TB-burden country11.

A study by de Jager CP1, 2012et al showed that. In an emergency care setting, both lymphocytopenia and Neutrophil-Lymphocyte Count Ratio (NLCR) are better predictors of bacteremia than routine parameters like CRP level, WBC count and neutrophil count. Attention to these markers is easy to integrate in daily practice and without extra costs12.

A study by Terradas R1, et al showed that. There is scarce evidence on the use of eosinophil count as a marker of outcome in patients with infection. The aim of this study was to evaluate whether changes in eosinophil count, as well as the neutrophil-lymphocyte count ratio (NLCR), could be used as clinical markers of outcome in patients with bacteremia. Conclusion: Both sustained eosinopenia and persistence of an Neutrophil-Lymphocyte Count Ratio (NLCR) >7 were independent markers of mortality in patients with bacteremia13.

6.3Objectives of the study

To find out the value of Neutrophil-Lymphocyte Count Ratio(NLCR)in Community Acquired Pneumonia (CAP).

To study Neutrophil-Lymphocyte Count Ratio (NLCR) as prognostic indicator in Community Acquired Pneumonia (CAP).

7

3

Materials and methods

7.1 Source of data

The study would be conducted in patients with Community Acquired Pnuemonia admitted

in Victoria, Bowring and lady Curzon hospitals which are attached to Bangalore Medical

Collage & Research Institution during the study period ofNovember 2015-May 2017

7.2 Methods of collection of data ( including sampling procedure, if any)

A. Study design : Prospective study

B. Study period : November 2015-May 2017

C. Place of study: Victoria Hospital and Bowring and Lady Curzon Hospital, Bangalore

Medical Collage & Research Institution , Bangalore

D. Sample size: Sample size will be 100 with diagnosed cases of Community Acquired

Pnuemonia

E. Inclusion Criteria:

1. All patients who are 18 years and above

2. Patients who have Community Acquired Pnuemonia Clinically suspected

Community Acquired Pnuemoniawill be defined as the presence of sign and

symptoms of consolidation with or without opacity on plain chest radiography

(new cough, sputum production, dyspnoea, hypo- or hyperthermia, altered

breathe sounds upon physical examination).

F. Exclusion Criteria:

1. Age less than 18y.

2. Immunocompromise individuals.

3. Coexisting malignancy

4

G. Methodology:

All adult patients admitted in Victoria and Bowring and Lady Curzon Hospital

who are suspected to have Community Acquired Pnuemonia will be studied.

Clinically suspected Community Acquired Pnuemonia will be defined as the

presence of sign and symptoms of consolidation with or without opacity on plain

chest radiography (new cough, sputum production, dyspnoea, hypo- or

hyperthermia, altered breathe sounds upon physical examination).

The severity will be calculated in allCommunity Acquired Pnuemoniapatients as

per validated CURB-65 score.

The purpose of the CURB-65 score is to calculate the probability of mortality in

patients with Community Acquired Pnuemonia.

H. Assessment tools :

1. Proforma for written informed patient consent. (Attachment-I)

2. CRUB – 65 score (Attachment-II)

3. Study proforma. (Attachment-III)

I. Statistical analysis :

Data will be analyses in SPSS – 17 version for descriptive statistic Chi square test.

DATA COLLECTION

Age, gender, current smoking status,

Co-morbidity (Diabetes mellitus,Chronic Obstructive Pulmonary Disease,Heart

Disease, Gastrointestinal Disease, Cerebrovascular Disease, Renal Disease And

Chronic Liver Disease), additional therapy prior to presentation

Clinical symptoms (mental status, body temperature, blood pressure, heart and

respiratory rate, oxygen saturation),

5

Laboratory data (CRP level, WBC count, absolute neutrophil count, absolute

lymphocyte count, Neutrophil-Lymphocyte Count Ratio (NLCR) and urea

nitrogen levels) and

Radiological findings (infiltrate/with or without opacity). Biomarkers were

measured in all patients as part of routine clinical care.

7.3 Does the study require any investigation or intervention to be conducted on patients or

other humans or animals? If so please describe briefly.

Yes

The study requires the following investigations to be conducted on patients with

Community Acquired Pneumonia (CAP).

Investigation:

Complete hemogram

CRP level,

Absolute neutrophil count,

Absolute lymphocyte count,

Neutrophil-lymphocyte count ratio

Urea nitrogen levels

Sputum for culture and sensitivityand AFB

Radiological findings (infiltrate/with or without opacity).

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes. Ethical clearance has been obtained from “Ethical clearance committee” of the

institution.

8 List of References

6

1. Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, et al. (2007) Infectious Diseases

Society of America/American Thoracic Society consensus guidelines on the management of community-

acquired pneumonia in adults. Clin Infect Dis 44 Suppl 2S27–72.

2.Christ-Crain M, Muller B (2007) Biomarkers in respiratory tract infections: diagnostic guides to

antibiotic prescription, prognostic markers and mediators. EurRespir J 30: 556–573.

3.Heyland DK, Johnson AP, Reynolds SC, Muscedere J (2011) Procalcitonin for reduced antibiotic

exposure in the critical care setting: A systematic review and an economic evaluation. Crit Care Med 39:

1792–1799.

4.Jilma B, Blann A, Pernerstorfer T, Stohlawetz P, Eichler HG, et al. (1999) Regulation of adhesion

molecules during human endotoxemia. No acute effects of aspirin. Am J RespirCrit Care Med 159: 857-

863Jilma B, Blann A, Pernerstorfer T, Stohlawetz P, Eichler HG, et al. (1999) Regulation of adhesion

molecules during human endotoxemia. No acute effects of aspirin. Am J RespirCrit Care Med 159: 857-

863.

5. Wyllie DH, Bowler IC, Peto TE (2005) Bacteraemia prediction in emergency medical admissions: role

of C reactive protein. J ClinPathol 58: 352–356

6.Zahorec (2001) Ratio of neutrophil to lymphocyte counts-rapid and simple parameter of systemic

inflammatiion and stress in critically ill. BratislLekListy 102: 5–14.

7. de Jager CP, van Wijk PT, Mathoera RB, de Jongh-Leuvenink J, van der Poll T, et al. (2010)

Lymphocytopenia and neutrophil-lymphocyte count ratio predict bacteremia better than conventional

infection markers in an emergency care unit. Crit Care 14: R192.

8. Ommen SR, Hodge DO, Rodeheffer RJ, McGregor CG, Thomson SP, et al. (1998) Predictive power of

the relative lymphocyte concentration in patients with advanced heart failure. Circulation 97: 19–22.

7

9. de Jager CP1, Wever PC, Gemen EF, Kusters R, van Gageldonk-Lafeber AB, van der Poll T, Laheij

RJ.

10Ateş H1, Ateş İ, Bozkurt B, Çelik HT, Özol D, Yldrm Z. Ann Lab Med. 2013 Mar;33(2):105-10.

11. Yoon NB1, Son C, Um SJ. Crit Care. 2010;14(5):R192.

12. de Jager CP1, van Wijk PT, Mathoera RB, de Jongh-Leuvenink J, van der Poll T, Wever PC. PLoS

One. 2012;7(8):e42860.

13..Terradas R1, Grau S, Blanch J, Riu M, Saballs P, Castells X, Horcajada JP, Knobel H.

14. Joshi VD, Kalvakolanu DV, Cross AS (2003) Simultaneous activation of apoptosis and inflammation

in pathogenesis of septic shock: a hypothesis. FEBS Lett 555: 180–184

15.Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, et al. (2006) Duration of hypotension before

initiation of effective antimicrobial therapy is the critical determinant of survival in human septic

shock.Crit Care Med 34: 1589–1596.

8

9 Signature of Candidate

10 Remarks of guide Community acquired pneumonia is a major cause of morbidity and mortality in hospitalized patients in our country. Neutrophil-lymphocyte count ratio was studied as an infection marker in ICU patients and found to correlate with disease severity and outcome. Neutrophil-lymphocyte count ratio is simple and better marker in predicting bacteremia in community acquired pneumonia patients and their outcome. Hence this studied is recommended.

11 11.1 Name and designation of the Guide

ASSOC. PROF DR. M. NARAYANSWAMY

11.2 Signature

11.3 Head of the Department Dr. VEERANNA GOWDAPROFESSOR AND HODDEPARTMENT OF MEDICINE Bangalore Medical Collage & Research Institution

11.4 Signature

12 12.1 Remarks of the Chairman and Principal

12.2 Signature

9

PATIENT INFORMATION AND CONSENT FORM

ATTACHMENT1SIGNATURE PAGE

To become part of this study and to authorize use and disclosure of your personal healthInformation, you or your legal representative must sign and date this page.

By signing this page, you are conforming the following:

1 You have read all of the information in this patient Information and Consent form, and you have had time to think of it.

2 All of your questions have been answered to your satisfaction.3 You voluntarily agree to be a part of this study.4 You refuse to participate or freely choose to stop being a part of this study at any

time.5 You allow the study doctor to use and disclose your personal health information as

described in this document.6 You agree that your sample can be used for any other studies.

------------------------------------ ----------------------------------------Signature of the patient (dd/mm/my)

------------------------------------- -----------------------------------------Patient name patient initials and number

----------------------------------------- ----------------------------------------Signature of Principal investigator (dd/mm/my)

Name of Principal investigator

I hereby state the study procedures were explained in detail and all questions were fully and clearly answered to the above maentioned participant.

------------------------------------------------------------------- Name of Individual Condunting Informed Consent

----------------------------------------------------------------- -------------------------- Signature of Individual Conducting Informed Consent (dd/mm/yy)

10

ATTACHMENT I

PROFORMA FOR WRITTEN INFORMED CONSENT

Date:

Place:

I Mr. /Mrs.Son/daughter/wife of Mr.aged about years, have been explained in a language

understood by me about the study entitled “study of neutrophil lymphocyte count ratio values in

community acquired pneumonia patients as a prognostic indicator.”at the department of General

medicine of Victoria hospital and Bowring and Lady Curzon hospital Bangalore.

I have been explained about the procedures and investigations that will be done during this study.

I have no objections in sharing my patient’s medical information and details in case records with

the investigators of this study.I have been informed that I will not be sharing any

incentives.Personal identity will not be revealed and data may be used for

publication/dissertation purpose.

I understand that my patient’s participation in this study is entirely voluntary and I willfully give

consent regarding participation of my patientin this study for the specified duration.

Signature of the caregiver

Relation with the patient Signature of the doctor

11

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13

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ATTACHMENT II

CURB-65:

CURB-65, also known as the CURB criteria, is a clinical prediction rule that has been

validated for predicting mortality in community-acquired pneumonia and infection of any

site. The CURB-65 is based on the earlier CURB score and is recommended by the British

Thoracic Society for the assessment of severity of pneumonia.

The score is an acronym for each of the risk factors measured. Each risk factor scores one

point, for a maximum score of 5:

Confusion of new onset (defined as an AMTS of 8 or less)

Blood Urea nitrogen greater than 7 mmol/l (19 mg/dL)

Respiratory rate of 30 breaths per minute or greater

Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less

age 65 or older

CURB-65

Symptom Points

Confusion 1BUN>7 mmol/l 1Respiratory rate>=30 1SBP<90mmHg, DBP=<60mmHg 1

14

Age>=65 1

Predicting death:

Pneumonia

The risk of death at 30 days increases as the score increases:

0—0.6%

1—2.7%

2—6.8%

3—14.0%

4—27.8%

5—27.8%

The CURB-65 has been compared to the pneumonia severity index in predicting

mortality from pneumonia. It was shown that the PSI has a higher discriminatory power

for short-term mortality, and thus is more accurate for low risk patients than the CURB-

65 or its predecessor, the CURB score. However, the PSI is more complicated and

requires arterial blood gas sampling amongst other tests; given this, the CURB-65 score

is more easily used in primary care settings. A variant of the CURB-65 that omits the

urea measurement (CRB-65) is even simpler, as it relies only on history and examination

findings rather than blood tests.

The CURB-65 is used as a means of deciding the action that is needed to be taken for that

patient.

0-1: Treat as an outpatient

2: Consider a short stay in hospital or watch very closely as an outpatient

3-5: Requires hospitalization with consideration as to whether they need to be in

the intensive care unit

Any infection

Patients with any type of infection (half of the patients had pneumonia), the risk of death

increases as the score increases:

0 to 1 <5% mortality

15

2 to 3 < 10% mortality

4 to 5 15-30% mortality

SOFA score

Respiratory System:

The Sequential Organ Failure Assessment score, or just SOFA score, is used to track a

patient's status during the stay in an intensive care unit (ICU). It is one of several ICU

scoring systems.

PaO2/FiO2 (mmHg) SOFA score

< 400 1< 300 2< 200 and mechanically ventilated 3< 100 and mechanically ventilated 4

16

ATTACHMENT III

STUDY PROFORMA

DATE:I.P. NO./O.P. NO. -

1. PATIENT INFORMATION:

NAME

AGE

SEX

I.P. NO./ O.P. NO. -

ADDRESS

OCCUPATION

2. HISTORY OF PRESENT ILLNESS:

17

3.PAST HISTORY:

DIABETES MELLITUS

HYPERTENSION

RENAL FAILURE

LIVER FAILURE

BRONCHIAL ASTHMA/COPD

TUBERCULOSIS

OTHERS

4. FAMILYHISTORY:

5. PERSONAL HISTORY:

DIET/SLEEP

BLADDER AND BOWEL HABITS

SMOKING

ALCOHOLISM

18

OTHER SUBSTANCE ABUSE

6.TREATMENT HISTORY:

7.GENERAL PHYSICAL EXAMINATION:

VITALS SIGNS BASELINE

Weight(kg)

Height(ft)

Temperature(degree Celsius)

Respiratory rate(per min)

Pulse rate(per min)

Blood pressure(mm Hg)

8.SYSTEMIC EXAMINATION:

CVS

RS

ABDOMEN

CNS

VII.INVESTIGATIONS:COMPLETE HEMOGRAM

CRP LEVELs

ABSULUTE NEUTROPHIL COUNT,ABSULUTE LYMPHOCYTE COUNTNEUTROPHIL-LYMPHOCYTE COUNT RATIO

19

UREA NITROGEN LEVELS

SPUTUM FOR C/S AND AFB

RADIOLOGICAL FINDINGS (INFILTRATE/WITH OR WITHOUT OPACITY)

20