| CTRI Number |
CTRI/2024/02/062654 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating early postoperative outcomes in liver transplant patients |
|
Scientific Title of Study
|
Early post Operative outcomes in liveR trAnsplant reCipients: A retrospective singLe center
Experience ORACLE STUDY |
| Trial Acronym |
ORACLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Pal |
| Designation |
Consultant |
| Affiliation |
Medanta the medicity |
| Address |
Department of critical care medicine and anesthesia Medanta - The Medicity
Sector 38, Gurgaon, Haryana
Gurgaon
HARYANA
122001
India
Gurgaon
HARYANA
122001
India |
| Phone |
7838316282 |
| Fax |
|
| Email |
divyapalarora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Pal |
| Designation |
Consultant |
| Affiliation |
Medanta the medicity |
| Address |
Department of critical care medicine and anesthesia Medanta - The Medicity
Sector 38, Gurgaon, Haryana
Gurgaon
HARYANA
122001
India
Gurgaon
HARYANA
122001
India |
| Phone |
7838316282 |
| Fax |
|
| Email |
divyapalarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Pal |
| Designation |
Consultant |
| Affiliation |
Medanta the medicity |
| Address |
Department of critical care medicine and anesthesia Medanta - The Medicity
Sector 38, Gurgaon, Haryana
Gurgaon
HARYANA
122001
India
Gurgaon
HARYANA
122001
India |
| Phone |
7838316282 |
| Fax |
|
| Email |
divyapalarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta the medicity
sector 38 Gurgaon Haryana |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Divya Pal |
Medanta the medicity |
ICU 09 ICU 10 ICU 11
Institute of Critical Care & Anaesthesiology
Medanta the medicity
Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA |
7838316282
divyapalarora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z482||Encounter for aftercare followingorgan transplant, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients more than 18 years of age who underwent liver transplant surgery will be included in the study |
|
| ExclusionCriteria |
| Details |
All adult patients less than 18 years of age will be excluded in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes of the study are evaluation of incidence of neurological respiratory cardiovascular renal infectious and surgical complications in first seven days post transplant |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes of the study are evaluation of incidence of primary non function early graft dysfunction within 7 days ICU length of stay Hospital length of stay, Mortality percentage Re transplantation within 7 days |
7 days |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
19/02/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a retrospective observational study on the early postoperative outcomes of liver transplant recipients who have undergone liver transplantation at Medanta the medicity, Gurugram. The study aims to identify potential complications in their early post-operative ICU stay and will be conducted after approval from institutional ethics committee. All adult patients more than 18 years of age who underwent liver transplant surgery will be included in the study. Primary outcomes of the study are evaluation of incidence of neurological, respiratory, cardiovascular, renal, infectious and surgical complications in first seven days post transplant. Secondary outcomes of the study are evaluation of incidence of primary non function/ early graft dysfunction (within 7 days of transplant), ICU length of stay, Hospital length of stay, Mortality percentage, Re transplantation within 7 days. |