Skip to content

Liver Donor Prehabilitation for Better Post Operative Recovery

Efficacy of Multimodal Prehabilitation of Liver Donors in enhancing Post Operative Recovery - A Randomized Controlled Study - PRE-DON TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076862
Enrollment
96
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 b

Sponsors

Amrita Institute Of Medical Science
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To compare the peak ALT (Alanine Aminotransferase) between the two groups.Timepoint: 1 to 2 weeks

Secondary

MeasureTime frame
Time of Normalization of Serum Bilirubin and PT-INR between the two groups.Timepoint: 1 to 2 weeks;Peak AST (Aspartate Aminotransferases), PT-INR(Prothrombin Time - International Normalized ratio) , Serum Bilirubin between the two groups.Timepoint: 1 to 2 weeks;Liver volume regeneration between the two groupsTimepoint: 2 to 3 weeks;Intraoperative liver biopsy (steatosis) between the two groups.Timepoint: At surgery;Liver-regeneration markers between the two groupsTimepoint: At Donor workup and at post op day 3;Blood loss , Hospital stay , Complication rate post surgery (Clavien Dindo Classification)Timepoint: 1 to 2 weeks;Rates of early graft dysfunction in recipients (Olthoff criteria)Timepoint: 1 to 2 weeks

Countries

India

Contacts

Public ContactDr Vinaya Chandra C

Amrita Institute Of Medical Science

sudhisalini@icloud.com9388623851

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026