| CTRI Number |
CTRI/2025/04/083977 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the factors affecting death of traumatic injury patients admitted in ICU. |
|
Scientific Title of Study
|
To determine the predictors influencing mortality among acute trauma patients admitted in ICU- 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 |
MANISHA CHAUDHARY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology ,King George Medical University ,Shah mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7906250813 |
| Fax |
|
| Email |
manishachaudhary2306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ZIA ARSHAD |
| Designation |
PROFESSOR |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology,King George Medical University ,Shah mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415722226 |
| Fax |
|
| Email |
ziaarshad13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ZIA ARSHAD |
| Designation |
PROFESSOR |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology, King George Medical University ,Shah mina Road, Chowk,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415722226 |
| Fax |
|
| Email |
ziaarshad13@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University, Lucknow, Uttar Pradesh , India 226003 |
|
|
Primary Sponsor
|
| Name |
Manisha Chaudhary |
| Address |
Department of Anaesthesiology
King George Medical University
Shahmina road, Chowk, Lucknow
Lucknow 226003 |
| Type of Sponsor |
Other [Self] |
|
|
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 ZIA ARSHAD |
King George Medical University |
Department of Anaesthesiology King George Medical University Shahmina RoadChowkLucknow 226003
Lucknow
UTTAR PRADESH |
09415722226
ziaarshad13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, (2) ICD-10 Condition: T07||Unspecified multiple injuries, (3) ICD-10 Condition: T07||Unspecified multiple injuries, (4) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients above 18 years of age with traumatic injuries admitted to ICU. |
|
| ExclusionCriteria |
| Details |
Patient dead within 48 hours of ICU admission
Not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate Trauma and Injury Severity Score, ICU Prognostic scores APACHE II and SOFA ,patient demographics, comorbidities and interval between trauma and admission to hospital |
Baseline data will be collected on admission. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of proposed variables on ICU stay & days of mechanical ventilation |
During mortality or discharge from ICU |
| To assess the effect of proposed variable on mortality, days of mechanical ventilation & days of ICU stay. |
Patient will be followed & secondary outcome will be assessed during mortality or discharge from ICU. |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
01/05/2025 |
| 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)
|
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
|
The study will be done at Critical Care Unit Department of Anesthesiology King George Medical University Lucknow. Patients will be treated according to ICU protocols. Epidemiologic data will be collected and the patients chart will be reviewed. The parameters to be assessed include demographic characteristics trauma severity scores of illness on admission and standard ICU scores and mechanism of trauma GCS PaO2/FiO2 Length of stay in ICU. Predictors of mortality will be assessed based on above parameters. |