| CTRI Number |
CTRI/2024/09/073243 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Neutrophil to Lymphocyte ratio and Platelet to Lymphocyte ratio as a Prognostic indicator for Post Operative laparotomy patients in Intensive care unit- A observational study |
|
Scientific Title of Study
|
Neutrophil to Lymphocyte Ratio and Platelet to lymphocyte Ratio as a prognostic indicator for Post Operative laparotomy patients in Intensive care unit- A Prospective Observational Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Manwar Ali |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar, |
| Address |
Room no 66, Department of General surgery, OPD
AIIMS Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9488820340 |
| Fax |
|
| Email |
alysmanwar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bansival Nareshkumar Manoharlal |
| Designation |
Junior Resident / Investigator |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of General surgery
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9586726126 |
| Fax |
|
| Email |
nareshbansival@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bansival Nareshkumar Manoharlal |
| Designation |
Junior Resident / Investigator |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of General surgery
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9586726126 |
| Fax |
|
| Email |
nareshbansival@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odisha 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of General surgery,
AIIMS Bhubaneswar
AIIMS,Bhubaneswar, Odisha |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Manwar Ali |
AIIMS Bhubaneswar |
Room no. 66, Department of General Surgery,Sijua,Patrapada
Khordha
ORISSA |
9488820340
alysmanwar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K950||Complications of gastric band procedure, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All patient age more than 18years who are taken up
for Laparotomy under Department of General Surgery and subsequently admitted in ICU for at- least 24hrs After Surgery.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Immunodeficiency disorder
3.Hematological disorder
4.Operated vitally stable patient otherwise normal in postoperative period if chosen for ICU Treatment after 24hrs.
5.Failed to understand or sign the informed consent will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survivor, Non survivor measurement |
till stay in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictability of the NLR & PLR in defining the ICU course. |
Baseline-At admission
then at 24hour & 48hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study Title: “Neutrophil to Lymphocyte ratio and Platelet to Lymphocyte ratio as a Prognostic indicator for Post Operative laparotomy patients in Intensive care unit- A Prospective observational studyâ€Study Objectives: Primary: To assess role of NLR and PLR for predicting the ICU Stay in post-operative laparotomy patient. Secondary:1. To compare predictability of NLR and PLR with other prognostic indicators like CRP, lactate, Procalcitonin. 2. To assess the cost benefit ratio. Study Design- Prospective Observational Study Study Setting- All post operative laparotomy patient admitted in ICU, All India Institute of Medical Science, Bhubaneswar. Study Groups - All patient age more than 18years operated under General Surgery Department Who are admitted to ICU after surgery for at-least 24hrs. Sample size- 150 Novelty: No studies have been so far published from India which predicts the course of post operative laparotomy ICU patient based on NLR and PLR. Participant Recruitment: will start after approval
|