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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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