| CTRI Number |
CTRI/2024/10/074730 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing Various Brain Monitors to predict Raised Cerebral Pressure and its Effect in Acute Liver Failure Patients. |
|
Scientific Title of Study
|
Comparison of Neuromonitoring Devices in Predicting Raised ICP and Outcome in ALF 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 |
Dr Aviral Srivastava |
| Designation |
Senior Resident |
| Affiliation |
Institute Of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia
Phase-2, 3rd Floor
Institute of Liver and Biliary Sciences
South
DELHI
110070
India |
| Phone |
9910784941 |
| Fax |
|
| Email |
aviralsrivastava1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Liver and Biliary Sciences |
| Address |
Department Of Anaesthesia
3rd Floor Phase 2
Institute Of Liver and Biliary Sciences
South
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aviral Srivastava |
| Designation |
Senior Resident |
| Affiliation |
Institute Of Liver and Biliary Sciences |
| Address |
Department Of Anaesthesia
Phase-2,3rd Floor
Institute Of Liver and Biliary Sciences
South
DELHI
110070
India |
| Phone |
9910784941 |
| Fax |
|
| Email |
aviralsrivastava1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Liver and Biliary Sciences,D-1 Vasant Kunj,Delhi-110070
India |
|
|
Primary Sponsor
|
| Name |
Institute Of Liver and Biliary Sciences |
| Address |
D-1 Vasant Kunj Road,
Ghitorni, New Delhi-110070 |
| 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 Aviral Srivastava |
Institute Of Liver and Biliary Sciences |
Department of Critical Care
Liver Coma ICU
3rd Floor,Phase-2
South
DELHI |
9910784941
aviralsrivastava1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee/Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K720||Acute and subacute hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acute Liver Failure Patients. |
|
| ExclusionCriteria |
| Details |
1)Acute on Chronic Liver Failure Patients.
2)Transcranial Doppler Window cannot be obtained. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Trans Cranial Doppler with Near Infrared Spectroscopy, BI-Spectral Index and Optic Nerve Sheath Diameter in predicting raised Intra Cranial Pressure related mortality in Acute Liver Failure patient. |
Outcome will be assessed at baseline and every 6hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Optic Nerve Sheath Diameter & TransCranial Doppler values will be compared.
Degree of agreement between Optic Nerve Sheath diameter, PI values, BIS & NIRS |
These values will be seen at baseline & every 6hourly |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/10/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) - student and researchers who are genuinely interested in the study for further research work.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aviralsrivastava1991@gmail.com].
- For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Studies are scarce and limited data is available about the use of different noninvasive neuromonitoring devices in acute liver failure patients and their correlation in predicting the outcome. All acute liver failure patients getting admitted in the ICU will be attached Near Infrared Spectroscopy and Bis electrodes and their charting will be done every hourly. Optic nerve sheath diameter and Pulsatality index values will be noted at admission and every 6hourly till the final outcome of the patient. These parameters will be observed in operation theatre if patient goes for Liver transplant.
|