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CTRI Number  CTRI/2024/01/061385 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 04/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Neutrophil Lymphocyte Ratio (NLR) for Prediction of Mortality in Sepsis patient 
Scientific Title of Study   Evaluation of Neutrophil Lymphocyte Ratio (NLR) for Prediction of Mortality in Adult Sepsis Patients of ICU 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Shankar 
Designation  PG resident 
Affiliation  school of medical sciences and research sharda university 
Address  Department of Anaesthesiology school of medical sciences and research sharda university greater noida knowledge park 3

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8368031687  
Fax    
Email  9shankargaurav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ram Murti Sharma 
Designation  Professor 
Affiliation  school of medical sciences and research sharda university 
Address  Department of Anaesthesia school of medical sciences and research sharda university greater noida knowledge park 3

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  7798881243  
Fax    
Email  sharmarammurti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ram Murti Sharma 
Designation  Professor 
Affiliation  school of medical sciences and research sharda university 
Address  Department of Anaesthesia school of medical sciences and research sharda university greater noida knowledge park 3

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  7798881243  
Fax    
Email  sharmarammurti@gmail.com  
 
Source of Monetary or Material Support  
school of medical sciences and research sharda university greater noida up 
 
Primary Sponsor  
Name  school of medical sciences and research sharda university 
Address  school of medical sciences and research sharda university greater noida knowledge park 3 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ram Murthy Sharma  Sharda Hospital  ICU, Block 2D Department of anaesthesiology and critical care
Gautam Buddha Nagar
UTTAR PRADESH 
7798881243

sharmarammurti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, SMS&R Sharda university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age above 18 years
2. Patients of either gender diagnosed of sepsis or septic shock
 
 
ExclusionCriteria 
Details  1. Pregnant female

2. Non-consenting patients and patient’s attendant
3. Immunocompromized or those with terminal or severe illness (advanced or metastatic cancer, advanced congestive heart failure, stroke, coma)
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Neutrophil Lymphocyte Ratio (NLR) for Prediction of Mortality in Adult Sepsis Patients of ICU  TILL THE PATIENT IS IN ICU or 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
(1) To calculate NLR ratio of adult sepsis patient in ICU.
(2) To estimate APACHE II score to predicted mortality.
(3) To find the correlation between NLR & APACHE II score.
 
TILL THE PATIENT IS IN ICU or 3 weeks 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Sepsis is defined as a life-threatening organ dysfunction where the host has a dysregulated immune response to infection. In early 1990s a consensus statement was developed by American College of Chest Physicians and the Society of Critical Care Medicine, they defined sepsis as systemic inflammatory response syndrome (SIRS) with or without positive blood culture. In 2016, Third International Consensus definitions for sepsis and septic shock were published 1.

 

The new consensus definition eliminated the terminology of SIRS and severe sepsis. Sepsis is considered as a life threatening organ dysfunction caused by a dysregulated host response to an infection. Sequential Organ Failure Assessment (SOFA) score was introduced. This scoring system based on organ dysfunction was used to define sepsis. Increase in SOFA score of 2 or more was considered to be diagnostic of sepsis. Septic shock is considered to be a subset of sepsis in which underlying circulatory and cellular or metabolic abnormalities are profound enough to increase mortality substantially1.

 

The burden of sepsis is very high in low and middle income countries and mortality remains very high thus early diagnosis of sepsis is of utmost importance in initiating treatment in sepsis.

In sepsis a hyper inflammatory response is followed by an immunosuppressive phase during which multiple organ dysfunction develops which will lead to hospital acquired infections. Neutrophil play a critical role in protecting the body from infections. Therefore, a dramatical increase in neutrophil count has been found in severe infectious diseases, especially in sepsis. Lymphopenia (reduced lymphocyte count) due to lymphocyte apoptosis is a prominent feature of sepsis, which may account for adaptive immunodepression.

 

  Among various marker studied over time, the neutrophil to lymphocyte ratio (NLR) recently emerged as a good marker to predict sepsis severity. The neutrophil to lymphocyte ratio (NLR) is easy to perform, complete blood count (CBC) being one of the standard blood tests routinely performed upon admission to ICU. This ratio can be calculated from both the absolute number of neutrophils and lymphocytes, and from their relative number 2

 

             

            Acute physiology and chronic health evaluation II (APACHE II) score is another commonly used indicator of severity of illness and prediction of mortality in ICU patients. It is commonly used in critically ill patients to predict outcome in both operative and non-operative cases 7.

 

 In this prospective observational study we will also study any correlation between NLR ratio and APACHE  II scoring while  predicting   mortality of sepsis patients.

 

Lacunae in existing knowledge:

 

NLR has been found to serve as a convenient prognostic marker in septic patients. Despite numerous pieces of evidence that reported the correlation between NLR and adverse outcomes of sepsis, it has remained controversial. NLR has previously been shown to predict adverse outcomes in adult oncology and stroke patients. It has also been used to predict adverse outcomes of bacterial meningitis patients in pediatric age group. Despite a large number of evidences confirmed an association between NLR and mortality, the relationship between NLR and outcomes of sepsis patient was rarely investigated. This study is planned to find whether NLR can predict mortality in adult sepsis patient of ICU.


 
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