Living Organ Donor Recovery Enhancement Program

Living Liver and Kidney Donors Clinical Trial

Official title:

Living Organ Donor Recovery Enhancement Program

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03865264
• Other study ID #: 015-280
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Living Liver and Kidney Donors

Intervention

Other:
• Recovery Enhancement Program
Behavioral, nutritional, physical and opioid-reduction pain medication

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RAND SF-36 questionnaires	Pre-operative emotional stress	From day of enrollment in the study (at least 4 weeks before surgery) up to 1 day prior to hepatectomy.
Primary	Level of pain experienced daily	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)
Primary	Duration in ICU	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.
Primary	Opioid usage	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.
Primary	RAND SF-36 questionnaires	Post-operative emotional stress	From month 1 to month 12 post transplantation.
Primary	Duration to return of daily activities	Duration to return of daily activities	From day of hospital discharge to 1 year follow up.
Primary	Incidence of Post-operative hospital re-admissions	Number of post-operative hospital re-admissions	From post-transplant discharge to 1 year follow-up