Living Organ Donor Recovery Enhancement Program

NCT ID: NCT03865264

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2024-01-22

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.

Conditions

Living Liver and Kidney Donors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Living Liver donor

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.

Group Type: ACTIVE_COMPARATOR

Recovery Enhancement Program

Intervention Type: OTHER

Behavioral, nutritional, physical and opioid-reduction pain medication

Living Kidney donor

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.

Group Type: ACTIVE_COMPARATOR

Recovery Enhancement Program

Intervention Type: OTHER

Behavioral, nutritional, physical and opioid-reduction pain medication

Living Kidney donor (Control)

1. Subjects maintain the same lifestyle without practicing physical training, relaxation skills or nutritional drink before and after the surgery.

2. To control post-op pain, subject will use medication per standard of care, including PCA pump.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Recovery Enhancement Program

Behavioral, nutritional, physical and opioid-reduction pain medication

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guiliano Testa, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Transplant Institute, Baylor University Medical Center

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

015-280

Identifier Type: -

Identifier Source: org_study_id