| CTRI Number |
CTRI/2024/05/066596 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Fever with special focus on Central fever in a traumatic brain injury patients admitted in Trauma ICU |
|
Scientific Title of Study
|
Fever with special emphasis on Central fever in a traumatic brain injury patients admitted in Trauma ICU: A Prospective Cohort 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 |
Sonal Goswami |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology , Institute of Medical sciences , Banaras Hindu University , Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7518408902 |
| Fax |
|
| Email |
sonal26mbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology , Institute of Medical sciences , Banaras Hindu University , Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8608617315 |
| Fax |
|
| Email |
ghanshyamx@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonal Goswami |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology , Institute of Medical sciences , Banaras Hindu University , Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7518408902 |
| Fax |
|
| Email |
sonal26mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , Institute of Medical science, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Sonal Goswami |
Trauma centre , Sir Sundarlal Hospital |
Department Of Anaesthesiology, First floor , Banaras Hindu University
Varanasi
UTTAR PRADESH |
7518408902
sonal26mbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S098||Other specified injuries of head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0 |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having fever episodes with history of traumatic brain injury
Traumatic brain injury patients requiring mechanical ventilation.
Body temperature more than 38 degree Celsius (100.94 degree Fahrenheit) at least for 2 consecutive days OR single episode of more than 39.5 degree Celsius (103.1 degree Fahrenheit)
|
|
| ExclusionCriteria |
| Details |
. Refusal to give consent
. History of Malignant Hyperthermia , heat stroke , neuroleptic malignant syndrome and serotonin syndrome
. Patient getting referred from other ICU facility
. Patient with possible endocrine issues ( like pheochromocytoma , adrenal crisis , thyrotoxicosis )
. Immunocompromised / on chemotherapy/ neutropenic patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analysis of the incidence of various causes of fever in Trauma ICU in traumatic brain injury patients. |
Within 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the association of various laboratory and clinical variables with the central fever in the patients of traumatic brain injury in Trauma ICU. |
Day1 ,Day3 and Day5 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
12/05/2024 |
| 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)
|
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
|
This study will be conducted in department of Anaesthesiology,IMS,BHU,Varanasi after obtaining written and informed consent and institutional ethical approval.After CTRI registration, patients fulfilling inclusion criteria will be included in this study and will be further evaluated by sending laboratory investigations and analyzing the clinical parameters. Demographic data and empirical antibiotics in use on patient will also be recorded. Various laboratory investigations include Complete blood count , C- reactive protein, chest X-ray , pro calcitonin levels and culture . Patients having positive culture reports will be classified as infectious fever and antibiotic escalation/deescalation will be done based on sensitivity report. Patients with negative culture report will be further evaluated to identify various other causes of fever and will be classified separately to calculate the incidence of various causes of fever . Patients included under neurogenic fever will be further evaluated and all the relevant clinical data from the onset of fever will be collected .This will include medical history , presenting symptoms and result of diagnostics tests. Based on objective of study , descriptive and inferential statistics will be drawn to determine the association of provided variables with neurogenic fever and a comprehensive list of variables will be formulated . This list will consists of variables that demonstrate high diagnostic accuracy for Central fever .
|