Recovery Enhancement Program for Living Organ Donors
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.12345Why 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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Participants undergo at least 4-6 weeks of physical and relaxation skills training pre-transplant
Intra-operative
Participants receive anesthesia and undergo surgery
Post-operative
Participants receive pain management and nutritional support post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including return to daily activities and emotional stress assessment
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?
3
Treatment groups
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor Research Institute
Lead Sponsor
Citations
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.pdfUpdate 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 ...
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.aspxLiving 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.
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.
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 ...
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.
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 ...
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