| CTRI Number |
CTRI/2021/01/030658 [Registered on: 21/01/2021] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, Observational |
| Study Design |
Other |
|
Public Title of Study
|
Factors Influencing decrease in thinking/reasoning/remebering function after living donor liver transplant surgery |
|
Scientific Title of Study
|
Factors Influencing decline in cognitive function after Living Donor Liver Transplant (LDLT)surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Mishra |
| Designation |
Fellow, Liver Transplant Anaesthesiology |
| Affiliation |
Medanta,The Medicity,Gurugram |
| Address |
Medanta, The Medicity
Department of Liver transplant anaesthesiology
Sec 39 Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
8153966303 |
| Fax |
|
| Email |
deepak4789mishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Mishra |
| Designation |
Fellow, Liver Transplant Anaesthesiology |
| Affiliation |
Medanta,The Medicity,Gurugram |
| Address |
Medanta, The Medicity
Department of Liver transplant anaesthesiology
Sec 39 Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
8153966303 |
| Fax |
|
| Email |
dXXXXXX789mishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Mishra |
| Designation |
Fellow, Liver Transplant Anaesthesiology |
| Affiliation |
Medanta,The Medicity,Gurugram |
| Address |
Medanta, The Medicity
Department of Liver transplant anaesthesiology
Sec 39 Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
8153966303 |
| Fax |
|
| Email |
deepak4789mishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of liver transplant anaesthesia, Medanta, the medicity, Gurugram |
|
|
Primary Sponsor
|
| Name |
Deepak Mishra |
| Address |
Medanta, The Medicity
Gurugram |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepak Mishra |
Medanta, the medicity, Gurugram |
Department of liver transplant anaesthesiology, Medanta, Sec 39
Gurugram
Gurgaon
HARYANA |
8153966303
dXXXXXX789mishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institue Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K730||Chronic persistent hepatitis, notelsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective LDLT |
|
| ExclusionCriteria |
| Details |
No previous neurological illness, ALF, On ventilator more than 7 days post operatively |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognitive function scores |
Cognitive function scores
Baseline, Post op day 7, Post op day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil( No secondary outcomes assessed) |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Living Donor Liver transplant is an extensive surgery, involving patients with chronic liver disease, who are chronically ill and have multisystem involvement. The aim of this study is to find out the factors affecting cognitive function in living donor liver transplant surgery . Following factors will be studied Age Duration of anaesthesia Pre op Na Pre op ammonia Co morbidities Etiology Blood transfusion
Results of the study will allow us to incorporate modifiable factors (patient selection,pre op optimization) and improve the outcome of surgery.
|