Living Organ Donor Recovery Enhancement Program

Not Applicable

• Conditions: Living Liver and Kidney Donors
• Interventions: Other: Recovery Enhancement Program

• Registration Number: NCT03865264
• Lead Sponsor: Baylor Research Institute

Brief Summary

The purpose of the study is to test if using these living donor-specific pre-transplant resources would lead to a better and faster recovery post-transplant.

Detailed Description

Donor safety and outcomes are the chief concerns of programs performing living donor liver and kidney transplantation. The protection of donors from physical and emotional harm has been a fundamental principle in living donor liver and kidney donation from the beginning. The safety of living donor hepatectomy and nephrectomy has been established. The risks associated with the donation have been deemed acceptable by the transplant community.

The investigators would like to move beyond the safety of the operation and address the most important post-operative issues that potentially cause donors physical and emotional stress: these include pain control, appropriate nutrition for optimal liver regeneration and physical/functional recovery, fatigue, time to return to normal physical and work activity, and difficulties coping with recovery and any possible complications. The goal of conducting this study is to create a program of pre- and post-operative interventions to enhance recovery so that patients can return to their normal quality of life as soon as possible. Currently there is no literature on programs to enhance living donor care and recovery.

This study will be conducted to determine if interventions during the pre-operative (a minimum of four weeks in an exercise program), intra-operative (anesthesia), and post-operative (pain management) stages have an effect on liver and kidney donor patients' quality of life and return to baseline functional status.

Study Timeline

• Study Start: 2017-04-20
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Ages ≥ 18 years
2. Cleared by a physician to participate in an exercise program
3. Approved for evaluation to be a living liver or kidney donor
4. Subjects willing and able to comply with the protocol procedures for the duration of the study, including the exercise regimen and scheduled follow-up visits
5. Subjects who have given IRB-approved written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Exclusion Criteria

1. Any co-morbidity restricting the subject's ability to walk alone
2. Pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Living Kidney donor	Recovery Enhancement Program	Recovery Enhancement Program 1. At least 4 weeks of physical and relaxation skills training pre-transplant. 2. Taking nutritional drink for 5 days before and after the surgery. 3. Opioid sparing pain management.
Living Liver donor	Recovery Enhancement Program	Recovery enhancement program: 1. At least 6 weeks of physical and relaxation skills training pre-transplant. 2. Taking nutritional drink for 5 days before and after the surgery. 3. Opioid sparing pain management.

Primary Outcome Measures

Name	Time	Method
Level of pain experienced daily	From day of admission into ICU (post-hepatectomy) up to day of hospital discharge (4-14 days post-hepatectomy)	level of pain per numerical rating pain scale (scale 0-10) with 0 being no pain and 10 being severe pain.
RAND SF-36 questionnaires	From month 1 to month 12 post transplantation.	Post-operative emotional stress
Incidence of Post-operative hospital re-admissions	From post-transplant discharge to 1 year follow-up	Number of post-operative hospital re-admissions
Opioid usage	From day of hospital discharge (post-hepatectomy) up to 1 year post hepatectomy.	Number of participants that require using opioid medication to treat abdominal and incisional pain post hepatectomy, medication strength and frequency of use.
Duration to return of daily activities	From day of hospital discharge to 1 year follow up.	Duration to return of daily activities
Duration in ICU	From day admission into ICU up to day of discharge to hospital floor or 14 days post hepatectomy, whichever came first.	Duration in ICU post-hepatectomy

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States