Clinical trial NCT03865264: Living Organ Donor Recovery Enhancement Program
Official title: Living Organ Donor Recovery Enhancement Program
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Living Liver and Kidney Donors
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: RAND SF-36 questionnaires
timeFrame: From day of enrollment in the study (at least 4 weeks before surgery) up to 1 day prior to hepatectomy.
measure: Level of pain experienced daily
timeFrame: From day of admission into ICU (post-hepatectomy) up to day of hospital discharge (4-14 days post-hepatectomy)
measure: Duration in ICU
timeFrame: From day admission into ICU up to day of discharge to hospital floor or 14 days post hepatectomy, whichever came first.
measure: Opioid usage
timeFrame: From day of hospital discharge (post-hepatectomy) up to 1 year post hepatectomy.
measure: RAND SF-36 questionnaires
timeFrame: From month 1 to month 12 post transplantation.
measure: Duration to return of daily activities
timeFrame: From day of hospital discharge to 1 year follow up.
measure: Incidence of Post-operative hospital re-admissions
timeFrame: From post-transplant discharge to 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Simmons Transplant Institute, Baylor University Medical Center
name: Guiliano Testa, MD
role: PRINCIPAL_INVESTIGATOR
References: