| CTRI Number |
CTRI/2024/08/072401 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Can Rising ratio of Neutrophil to Lymphocyte within normal range of total leukocyte be considered as a predictor of Sepsis in critically ill trauma patients |
|
Scientific Title of Study
|
Can Rising Neutrophil Lymphocyte Ratio within the normal range of Total Leukocyte Count be considered as an early and economical predictor for sepsis in critically ill trauma patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kairidibo |
| Designation |
Post Doctoral Fellow |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Trauma ICU IMS BHU Varanasi UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8014784391 |
| Fax |
|
| Email |
kairidibochewang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Trauma ICU
Department of Anaesthesiology and Critical Care
Trauma Centre IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Trauma ICU
Department of Anaesthesiology and Critical Care
Trauma Centre IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Lanka Varanasi Uttar Pradesh 221005 |
| 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 Kairidibo |
Department of Anaesthesiology |
Trauma ICU Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH |
8014784391
kairidibochewang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (2) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All Patients admitting in Trauma ICU for at least for 1 week. |
|
| ExclusionCriteria |
| Details |
ICU stay of less than 1 week.
Massive blood transfusion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the rise in Neutrophil-Lymphocyte ratio within the normal Total Leukocyte Count as an early and economical predictor for sepsis in post-traumatic patients admitting in ICU |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To look for association of NLR and other clinical and laboratory parameters with sepsis in different subgroups of patients:
ï¶ Patients with traumatic brain injury who underwent surgery for the same.
ï¶ Patient with cardiovascular disease
ï¶ Haematological disease
ï¶ Patient on an immunosuppressant drug.
ï¶ Patient with malignancy.
ï¶ Severe hepatic or renal disease.
ï¶ Paediatric age group Patients
ï¶ Geriatric patients
ï¶ Pregnant patient.
|
6 Months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/09/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Over the period of 6 months, patients admitting in Trauma ICU(if consented) will be enrolled for the observational prospective study on the role of Neutrophil Lymphocyte ratio trends over the course of time to predict the impending sepsis in trauma patients. At the same time we will also be looking on the trends of other markers of sepsis like Lactate, TLC, Cultures, Procalcitonin, SOFA Score, etc. |