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
|
|
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
|
|
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. |