Living Liver and Kidney DonorsNCT03865264
Living Organ Donor Recovery Enhancement Program
A study testing Recovery Enhancement Program in people with Living Liver and Kidney Donors, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Living Liver and Kidney Donors
- What is being tested?
- Recovery Enhancement Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 22 Jan 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages ≥ 18 years
- Cleared by a physician to participate in an exercise program
- Approved for evaluation to be a living liver or kidney donor
- 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
- 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Who cannot join
- Any co-morbidity restricting the subject's ability to walk alone
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
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.
Read the 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
- Being tested
- Recovery Enhancement Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Enhancement ProgramOther
Behavioral, nutritional, physical and opioid-reduction pain medication
| Study group | Role | What they receive |
|---|---|---|
| Living Liver donor | Active comparator | 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. Receives: Other: Recovery Enhancement Program |
| Living Kidney donor | Active comparator | 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. Receives: Other: Recovery Enhancement Program |
| Living Kidney donor (Control) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
RAND SF-36 questionnaires
Pre-operative emotional stress
Measured: 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
level of pain per numerical rating pain scale (scale 0-10) with 0 being no pain and 10 being severe pain.
Measured: From day of admission into ICU (post-hepatectomy) up to day of hospital discharge (4-14 days post-hepatectomy)
Duration in ICU
Duration in ICU post-hepatectomy
Measured: From day admission into ICU up to day of discharge to hospital floor or 14 days post hepatectomy, whichever came first.
Opioid usage
Number of participants that require using opioid medication to treat abdominal and incisional pain post hepatectomy, medication strength and frequency of use.
Measured: From day of hospital discharge (post-hepatectomy) up to 1 year post hepatectomy.
RAND SF-36 questionnaires
Post-operative emotional stress
Measured: From month 1 to month 12 post transplantation.
Duration to return of daily activities
Duration to return of daily activities
Measured: From day of hospital discharge to 1 year follow up.
Incidence of Post-operative hospital re-admissions
Number of post-operative hospital re-admissions
Measured: From post-transplant discharge to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start20 Apr 2017
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Why it stopped: study lost funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Liver and Kidney DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guiliano Testa, MD, Principal investigator, Simmons Transplant Institute, Baylor University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865264
- Sponsor's protocol ID
- 015-280
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2018
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No