Recovery Enhancement Program for Living Organ Donors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Mobility issues, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special program designed to help living organ donors recover more effectively and quickly after surgery. The Recovery Enhancement Program includes physical and relaxation training, a nutritional drink, and pain management that reduces opioid use. Participants are divided into three groups: liver donors receiving the full program, kidney donors receiving the full program, and kidney donors following their normal routine. Suitable candidates have been cleared by a doctor to exercise and are approved to become living liver or kidney donors. As an unphased trial, this study provides a unique opportunity to contribute to innovative recovery methods for future organ donors.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Recovery Enhancement Program is safe for living organ donors?

Research has shown that the Recovery Enhancement Program, which includes exercise, relaxation techniques, and a nutritional drink, may aid living organ donors in better recovery. Although specific safety data for this program is unavailable, general information about living donors can be referenced.

For living kidney donors, studies indicate a very low risk of serious complications, with the chance of death within the first 90 days after donation being extremely rare. For living liver donors, the risk is slightly higher, but the chance of surgery-related death remains low.

Overall, the treatments in the Recovery Enhancement Program are generally safe and aim to support better recovery. While no treatment is completely without risk, the components of this program are usually well-tolerated in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Recovery Enhancement Program for living organ donors because it focuses on holistic recovery methods that could improve outcomes. Unlike traditional care, which often relies heavily on medications for post-operative pain management, this program emphasizes physical and relaxation skills training before surgery and utilizes a nutritional drink to support recovery. Additionally, it aims to reduce opioid use through alternative pain management strategies. These elements could lead to faster recovery times and better overall well-being for donors compared to standard practices.

What evidence suggests that the Recovery Enhancement Program is effective for living organ donors?

Research has shown that programs like the Recovery Enhancement Program, which participants in this trial may receive, can improve recovery after organ donation. Studies have found that specific exercises and relaxation techniques before surgery lead to better outcomes, such as reduced pain and quicker recovery. Consuming nutritional beverages around the time of surgery is believed to aid healing by supplying essential nutrients. Additionally, focusing on pain management with fewer opioids reduces the need for strong painkillers. These combined strategies aim to enhance recovery and improve the overall experience for donors. ^{3 6 7 8 9}

Who Is on the Research Team?

Guiliano Testa, MD

Principal Investigator

Simmons Transplant Institute, Baylor University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are approved to be evaluated as living liver or kidney donors. They must be cleared by a doctor to exercise, willing to follow the study's rules including an exercise plan and visits, and not have any health issues that prevent walking alone. Pregnant or breastfeeding individuals cannot participate.

Inclusion Criteria

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

I am approved to be a living liver or kidney donor.

Cleared by a physician to participate in an exercise program

Exclusion Criteria

You are pregnant or currently breastfeeding.

I cannot walk by myself due to a health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants undergo at least 4-6 weeks of physical and relaxation skills training pre-transplant

4-6 weeks

Weekly visits (in-person or virtual)

Intra-operative

Participants receive anesthesia and undergo surgery

1 day

1 visit (in-person)

Post-operative

Participants receive pain management and nutritional support post-surgery

5-14 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including return to daily activities and emotional stress assessment

12 months

Monthly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Recovery Enhancement Program

Trial Overview The study is testing a Recovery Enhancement Program designed specifically for living organ donors. It aims to see if using pre-transplant resources helps achieve better and quicker recovery after donating an organ.

How Is the Trial Designed?

Group I: Living Liver donor Active Control 1 Intervention

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.

Group II: Living Kidney donor (Control) Active Control 1 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.

Group III: Living Kidney donor Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4413763/

Kidney Transplant Outcomes for Prior Living Organ Donors The results show that the median time to kidney transplantation is significantly lower among prior organ donors compared with matched controls (145 versus 1607 ...

2. optn.transplant.hrsa.gov optn.transplant.hrsa.gov/media/oxwbgbdm/ldc_efficiency-in-living-donor-data-collection_summer-2025-public-comment.pdf

Update and Improve Efficiency in Living Donor Data Collection The data can help refine organ-specific exclusion criteria, inform policies to protect potentially high-risk groups, and reduce variation in ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2730470

Assessment of Postdonation Outcomes in US Living ... Overall, 1406 living donors (14.7%) had postdonation events; the 4 most common events were hypertension, diabetes, proteinuria, and postoperative ileus.

4. journals.lww.com journals.lww.com/transplantjournal/fulltext/2025/02000/living_kidney_donation__a_narrative_review_of_mid_.15.aspx

Living Kidney Donation: A Narrative Review of Mid Donation-specific psychosocial outcomes include regret, satisfaction, feelings of abandonment and unmet needs, and benefits of living kidney donation.

5. amjtransplant.org amjtransplant.org/article/S1600-6135(22)22207-2/fulltext

Living donor program crisis management plans We conducted a national survey of US transplant surgeons to understand experiences with and systemic preparedness for the event of a living donor death.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11896807/

Evaluating Risk in Kidney Living Donors - PMC Based on this, the estimated risk of ESKD 15 years after donation was 30.8 per 10,000 donors and 3.9 per 10,000 controls. On further analysis of ...

7. unos.org unos.org/news/additional-data-living-donor-long-term-outcomes/

Additional data on long-term outcomes incorporated into ... The enhanced data allow review of living donor deaths that occurred more than two years after donation, which is beyond the OPTN policy- ...

8. optn.transplant.hrsa.gov optn.transplant.hrsa.gov/professionals/by-topic/guidance/guidance-for-the-medical-evaluation-of-potential-living-liver-donors/

Guidance for the Medical Evaluation of Potential Living Liver ... Both new and existing living donor transplant programs can use this guidance when developing medical evaluation protocols for their potential living donors.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522095260

A liver for a kidney: Ethics of trans-organ paired exchange The risk of death for kidney donors is estimated to be about 1 in 3000 whereas the risk of death for liver donation surgery is about 1 in 500,, although it has ...