Living Organ Donor Recovery Enhancement Program

January 28, 2024 updated by: Baylor Research Institute
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.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral, nutritional, physical and opioid-reduction pain medication
Active Comparator: 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.
Behavioral, nutritional, physical and opioid-reduction pain medication
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAND SF-36 questionnaires
Time Frame: From day of enrollment in the study (at least 4 weeks before surgery) up to 1 day prior to hepatectomy.
Pre-operative emotional stress
From day of enrollment in the study (at least 4 weeks before surgery) up to 1 day prior to hepatectomy.
Level of pain experienced daily
Time Frame: 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.
From day of admission into ICU (post-hepatectomy) up to day of hospital discharge (4-14 days post-hepatectomy)
Duration in ICU
Time Frame: 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
From day admission into ICU up to day of discharge to hospital floor or 14 days post hepatectomy, whichever came first.
Opioid usage
Time Frame: 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.
From day of hospital discharge (post-hepatectomy) up to 1 year post hepatectomy.
RAND SF-36 questionnaires
Time Frame: From month 1 to month 12 post transplantation.
Post-operative emotional stress
From month 1 to month 12 post transplantation.
Duration to return of daily activities
Time Frame: From day of hospital discharge to 1 year follow up.
Duration to return of daily activities
From day of hospital discharge to 1 year follow up.
Incidence of Post-operative hospital re-admissions
Time Frame: From post-transplant discharge to 1 year follow-up
Number of post-operative hospital re-admissions
From post-transplant discharge to 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guiliano Testa, MD, Simmons Transplant Institute, Baylor University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 015-280

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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