Living Organ Donor Recovery Enhancement Program

Baylor Scott and White Health (BSWH)

Status: Terminated

Conditions: Living Liver and Kidney Donors

Treatments: Other: Recovery Enhancement Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03865264

015-280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Living Liver donor

Active Comparator group

Description:

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.

Treatment:

Other: Recovery Enhancement Program

Living Kidney donor

Active Comparator group

Description:

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.

Treatment:

Other: Recovery Enhancement Program

Living Kidney donor (Control)

No Intervention group

Description:

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.