| CTRI Number |
CTRI/2024/12/078312 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early extubation in children undergoing living donor liver transplant |
|
Scientific Title of Study
|
FAST TRACKING IN PEDIATRIC LIVING DONOR LIVER TRANSPLANT-A road less travelled….. |
| 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 Amit Singhal |
| Designation |
Director |
| Affiliation |
BLK Max Superspeciality Hospital |
| Address |
Department of HPB and Liver Transplant Anaesthesia and critical care, BLK Max Superspeciality Hospital,
Pusa road
New Delhi
DELHI
110005
India |
| Phone |
9891873774 |
| Fax |
|
| Email |
drsinghalamit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Singhal |
| Designation |
Director |
| Affiliation |
BLK Max Superspeciality Hospital |
| Address |
Department of HPB and Liver Transplant Anaesthesia and critical care, BLK Max Superspeciality Hospital,
Pusa road
New Delhi
DELHI
110005
India |
| Phone |
9891873774 |
| Fax |
|
| Email |
drsinghalamit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Singhal |
| Designation |
Director |
| Affiliation |
BLK Max Superspeciality Hospital |
| Address |
Department of HPB and Liver Transplant Anaesthesia and critical care, BLK Max Superspeciality Hospital,
Pusa road
New Delhi
DELHI
110005
India |
| Phone |
9891873774 |
| Fax |
|
| Email |
drsinghalamit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amit Singhal |
| Address |
BLK Max Superspeciality Hospital |
| Type of Sponsor |
Other [Non funded study] |
|
|
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 Amit Singhal |
BLK Max Superspeciality Hospital |
Department of HPB and Liver Transplant Anaesthesia and critical care,
Second floor,
Organ Transplant ICU
New Delhi
DELHI |
9891873774
drsinghalamit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DEPARTMENT OF ACADEMIC AFFAIRS RESEARCH & CONTINUING EDUCATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients (Aged 3 months to 10 years) who underwent living donor liver transplants from January 2022 to June 2024.
|
|
| ExclusionCriteria |
| Details |
Patients with acute liver failure and hepatic encephalopathy grade 2 or above will be excluded from the analysis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Our primary outcome is to evaluate the early extubation rate after liver transplant in the paediatric population and demonstrate its safety across all ages. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Our secondary outcome is to determine predictive factors for successful early extubation in this population. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
We will perform a retrospective observational study and analyse the data of paediatric patients (Aged 3 months -10 years) who underwent LDLT from January 2022 to June 24. Our primary outcome is to evaluate the early extubation rate after liver transplant in the paediatric population and demonstrate its safety across all ages. Our secondary outcome is to determine predictive factors for successful early extubation in this population. Graph pad PRISM version will be used to analyse the data Paediatric patients who underwent LDLT will be enrolled in the study. They will be divided into two groups - The early extubation (EE) group (extubated on-table or ≤4 hours postoperatively) and the delayed extubation (DE) group (mechanically ventilated > 4 hours postoperatively). Patients will be compared based upon demographic characteristics, intraoperative and postoperative data. We hypothesise that fast-tracking in paediatric patients is feasible and safe. |