| CTRI Number |
CTRI/2024/11/076862 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Multimodal Prehabilitation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Liver Donor Prehabilitation for Better Post Operative Recovery |
|
Scientific Title of Study
|
Efficacy of Multimodal Prehabilitation of Liver Donors in enhancing Post Operative Recovery - A Randomized Controlled Study |
| Trial Acronym |
PRE-DON TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinaya Chandra C |
| Designation |
MCh GI surgery Resident |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation, AIMS, Kochi
Amrita Institute Of Medical Science
Ernakulam , Kerala
Ernakulam KERALA 682041 India |
| Phone |
9164280199 |
| Fax |
|
| Email |
vinayachandra13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sudhindran S |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation, AIMS, Kochi
Amrita Institute Of Medical Science
Ernakulam , Kerala
Ernakulam KERALA 682041 India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhisalini@icloud.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vinaya Chandra C |
| Designation |
MCh GI surgery Resident |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation, AIMS, Kochi
Amrita Institute Of Medical Science
Ernakulam , Kerala
Ernakulam KERALA 682041 India |
| Phone |
9164280199 |
| Fax |
|
| Email |
vinayachandra13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation, AIMS, Kochi
Amrita Institute Of Medical Science
Ernakulam , Kerala , India
pincode : 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Science |
| Address |
Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation, AIMS, Kochi
Amrita Institute Of Medical Science
Ernakulam , Kerala |
| Type of Sponsor |
Private medical college |
|
|
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 Vinaya Chandra |
Amrita Hospital |
Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation, AIMS, Kochi
Amrita Institute Of Medical Science
Ernakulam , Kerala
Ponekkara Rd, P.O. Edapally, Kochi, Ernakulam, Keala 682041 Ernakulam KERALA |
9164280199
vinayachandra13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIMS, Kochi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prospective liver donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
Standard Of Care for Donor workup and surgery according institutional protocol |
| Intervention |
Multimodal Prehabilitation - Study Arm |
Monitored High Intensity Interval Training (HIIT) exercise, at least 2 weeks before surgery, practiced atleast once daily, taught to the donors by our PMR department
Inspiratory muscle training (IMT) and Incentive Spirometry (IS), at least 2 weeks before surgery, practiced atleast once daily taught to the donors by our PMR department
A high protein, low fat diet with total calorie intake equalling the basal requirement for at least 2 weeks before surgery, by our clinical nutritionist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Voluntary healthy donors, between the age group of 18 to 60 years, having a body mass index (BMI) between 18 and 30 kg/m2, emotionally related to the patient, medically fit, and without any psychiatric illness, after being evaluated in a stepwise manner and deemed fit for donor hepatectomy through our institution’s protocol. |
|
| ExclusionCriteria |
| Details |
Donors undergoing liver donation for emergency Liver Transplant are Excluded
Donors with fatty liver with LAI 9Liver Spleen Attenuation index) Less than (-9) at any point during their donor workup |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the peak ALT (Alanine Aminotransferase) between the two groups. |
1 to 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of Normalization of Serum Bilirubin and PT-INR between the two groups. |
1 to 2 weeks |
| Peak AST (Aspartate Aminotransferases), PT-INR(Prothrombin Time - International Normalized ratio) , Serum Bilirubin between the two groups. |
1 to 2 weeks |
| Liver volume regeneration between the two groups |
2 to 3 weeks |
| Intraoperative liver biopsy (steatosis) between the two groups. |
At surgery |
| Liver-regeneration markers between the two groups |
At Donor workup and at post op day 3 |
| Blood loss , Hospital stay , Complication rate post surgery (Clavien Dindo Classification) |
1 to 2 weeks |
| Rates of early graft dysfunction in recipients (Olthoff criteria) |
1 to 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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)
|
01/12/2024 |
| 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
|
All individuals being worked up under the Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation for Donor Hepatectomy will be recruited in the study after obtaining written informed consent. Demographic details (Patient’s Name, Age, Phone number and Gender), and Anthropometric parameter (Height, Weight, BMI, Waist circumference) are recorded. Patient comorbidities (diabetes, hypertension, dyslipidaemia and hypothyroidism) are documented. Donors are randomly assigned to 2 groups using computer generated randomization to a study and a control arm by the randomization protocol explained above. Patients in the study arm are subjected to a minimum of 2 weeks of prehabilitation which include: - Tailored Monitored High Intensity Interval Training (HIIT) exercise, A high protein, low fat diet with total calorie intake equalling the basal requirement and education and encouragement to practice Inspiratory muscle training (IMT) and Incentive Spirometry (IS). Baseline laboratory investigations include, CBC, LFT, RFT, Lipid profile, PT - INR, S.E and Liver regeneration markers. Intra operatively, Wedge liver biopsy is taken in all the Graft livers during bench preparation. Following the Donor Hepatectomy, the donors are observed in the ICU for 3/4 days and later shifted to the ward. Routine labs including LFT and PT-INR are done daily, and they are usually discharged by day 6/7 in case of an uneventful post-op period. Follow up is done after 14-21 days with routine labs and Plain CT to check for liver regeneration volumetry. |