- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865264
Living Organ Donor Recovery Enhancement Program
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75246
- Baylor University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Exclusion Criteria:
- Any co-morbidity restricting the subject's ability to walk alone
- Pregnant or breast-feeding women
Study Plan
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:
|
Behavioral, nutritional, physical and opioid-reduction pain medication
|
Active Comparator: Living Kidney donor
Recovery Enhancement Program
|
Behavioral, nutritional, physical and opioid-reduction pain medication
|
No Intervention: Living Kidney donor (Control)
|
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
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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
Sponsor
Investigators
- Principal Investigator: Guiliano Testa, MD, Simmons Transplant Institute, Baylor University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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