Kidney Donor Outcomes Cohort (KDOC) Study
Live donor kidney transplantation (LDKT) is important because its outcomes for recipients are superior to those of deceased donor transplantation, and it yields significant cost savings to the healthcare system overall. Despite efforts over the past few decades to enhance understanding of the short- and long-term outcomes of living kidney donation, it is clear that investigators have more knowledge in some areas (e.g., surgical and medical complications) than in others (e.g., psychological outcomes, financial impact). While the transplant community and changes in federal regulations have brought attention to the need for more systematic study of living donor outcomes, there remains a paucity of scientifically rigorous multisite, prospective outcome studies. The long-term goal of this research program is to characterize the short- and long-term surgical, medical, functional, psychological, and financial outcomes of living kidney donation. The objective of this study is to establish a multisite prospective cohort of living kidney donors, their recipients, and a healthy comparison group. This cohort will be used to examine three primary aims: (1) to assess donor outcomes (surgical, medical, functional, psychological, financial) over a 2-year period initially, with the intention of examining these outcomes over a more extended time period in subsequent years; (2) to identify the donor, recipient, and center variables that are most predictive of donor outcomes; and (3) to identify disparities in donor outcomes and their predictors. To accomplish these aims, six kidney transplant programs, representing six states (Massachusetts, Maine, Rhode Island, New York, Iowa, and Arizona) and with experience and expertise in caring for living donors and transplant recipients, will participate in the study. Donors, their recipients, and healthy controls will complete comprehensive assessments at baseline (pre-surgery) and at 1, 6, 12, and 24 months post-donation. This study will extend the investigators considerable preliminary work by simultaneously examining outcomes that are of importance to donors, recipients, healthcare providers, and policymakers. The rationale for this research is that, once these outcomes and their predictors are known, investigators can further develop and refine educational strategies and informed consent processes for both living donors and their intended recipients, as well as provide systematic data to inform policy discussions and clinical care practice.
Living Donor Nephrectomy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Kidney Donor Outcomes Cohort (KDOC) Study|
- Surgical Outcomes [ Time Frame: 1, 6, 12, and 24 Months Post-Surgery ] [ Designated as safety issue: No ]Multiple surgical outcomes will be measured, including: operative time, surgical complications, re-operation, hospital length of stay, wound pain intensity, surgical scarring, and hospital readmissions.
- Medical Outcomes [ Time Frame: Baseline (pre-donation), 1, 6, 12, and 24 Months Post-Surgery ] [ Designated as safety issue: No ]Multiple medical outcomes will be measured, including: blood pressure, creatinine, body mass index, serum creatinine, 24 hr creatinine clearance, 24 hr protein, 24 hr albumin, fasting glucose, hemoglobin, total cholesterol, LDL, and HDL.
- Functional Outcomes [ Time Frame: Baseline, 1, 6, 12, and 24 Months Post-Surgery ] [ Designated as safety issue: No ]Several functional outcomes will be measured, including: health-related quality of life, fatigue, physical activity, and return to work/school.
- Psychological Outcomes [ Time Frame: Baseline, 1, 6, 12, and 24 Months Post-Surgery ] [ Designated as safety issue: No ]Multiple psychological outcomes will be measured, including: donation pressure/coercion, mood, body image, donation benefits, life satisfaction, fear of kidney failure, decision stability, and donor-recipient relationship.
- Costs [ Time Frame: Baseline, 1, 6, 12, and 24 Months Post-Surgery ] [ Designated as safety issue: No ]We are assessing the financial impact of living kidney donation by assessing both direct and indirect costs associated with donor evaluation, surgical recovery and rehabilitation, and long-term recovery.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Living Kidney Donor, Transplant Recipient, Healthy Control
Living kidney donors and their transplant recipient will be enrolled. Also, a smaller cohort of healthy controls (potential donors who were medically suitable but not used) will be enrolled.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427452
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States|
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States|
|United States, Ohio|
|Cleveland, Ohio, United States|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States|
|Principal Investigator:||James R Rodrigue, Ph.D.||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Didier Mandelbrot, M.D.||Beth Israel Deaconess Medical Center|