| CTRI Number |
CTRI/2024/09/073246 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of inflammatory markers with trauma severity scores in critically ill trauma elderly patients |
|
Scientific Title of Study
|
Study of inflammatory markers in critically ill trauma elderly patients and its correlation with trauma severity score: a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Logesh R |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9442307171 |
| Fax |
|
| Email |
mailme2logesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Prakash |
| Designation |
Professor |
| Affiliation |
Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453047154 |
| Fax |
|
| Email |
drshashiprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Logesh R |
| Designation |
Junior Resident |
| Affiliation |
Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9442307171 |
| Fax |
|
| Email |
mailme2logesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| By Institute of Medical Sciences, Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Logesh R |
Institute of Medical Sciences, Banaras Hindu University |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH |
9442307171
mailme2logesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences_ethics _committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inflammatory biochemical markers in critically ill trauma elderly patients |
Blood samples for Inflammatory biochemical markers- TNF-alpha, IL-6 and CRP will be taken at 24 hours of trauma as a baseline investigation and procalcitonin will be taken at 72 hours of trauma as a baseline investigation.The total duration of study is 30 days for a patient and no further follow up samples will be taken.
|
| Comparator Agent |
Trauma Severity Scores in critically ill trauma elderly patients |
The trauma scores- Revised Trauma Score, Injury Severity Score, Trauma and Injury Severity Score, Probability of Survival- Ps17 and Geriatric Trauma Outcome Score will be assessed at the time of admission as Baseline, only once.The total duration of study is 30 days for a patient and no further assessment will be done during follow up period. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Geriatric patients of age between 60 and 99 years
2.Geriatric trauma patients requiring ICU admissions |
|
| ExclusionCriteria |
| Details |
1.Non traumatic causes requiring ICU admissions
2.Patients dying within first 24 hours of trauma /died in the Emergency Department
3.Patients with known pre-existing immunological
disorders and malignancies
4.Patients on immunosuppressants and anticoagulants
5.patients discharged against medical advice
6.patients/attendants of patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To correlate inflammatory markers with trauma severity score. |
1.Initial baseline inflammatory markers and trauma severity scores will be taken to correlate 30 day mortality. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Length of hospital stay
|
Patient will be assessed every 24 hours after admission till discharge/death of patient whichever is earlier |
| 2.Requirement of mechanical ventilation/vasopressors |
Patient will be assessed every 24 hours after admission till discharge/death of patient whichever is earlier |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
02/09/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study will be carried out in patients who will be admitted to ICU, Trauma Centre, Institute of Medical Sciences, Banaras Hindu University. Patient data will be collected from the patient/ relative and from the admission record. Data is collected in the form of age and sex of the patient, date and time of injury, date and time of admission to ICU, severity of injury in the form of trauma scorings - 1. Revised Trauma Score (RTS), 2. Injury Severity Score (ISS), .3 Trauma and Injury Severity Score (TRISS), 4. Probability of Survival (Ps17) and 5. Geriatric Trauma Outcome Score (GTOS).
Within 24 hours of trauma, the blood samples for IL-6, TNF-alpha, PCT and at 72 hours for CRP will be sent to lab where the samples undergo cooling centrifugation, plasma will be aliquoted, frozen and stored. Levels of biomarkers will be assessed after final sample collected using ELISA method. In the meantime, patient will be followed up every 24 hours for 30 days for assessing 30-day mortality. In addition, the patients assessed every 24 hours for length of hospital stay and use of mechanical ventilation/ vasopressors till the discharge / death of the patient whichever is earlier.
The obtained data will be recorded and the results will be statistically analysed by appropriate statistical methods. A p value of 0.05 will be considered as significant.
|