Remote Ischemic Preconditioning in Neurological Death Organ Donors (RIPNOD)
The purpose of this study is to determine whether application of lower limb remote ischemic preconditioning (RIPC) after determination of brain death improves donor stability, organ quality, organ yield, and early post transplant clinical outcomes.
Neurological death donors will be stratified into standard and extended criteria donors (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state, donor organ-specific function parameters, pulsatile perfusion parameters, number of organs transplanted per donor, recipient hospital free survival and delayed graft function of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Remote Ischemic Preconditioning in Neurological Death Organ Donors|
- Number of organs recovered per donor [ Time Frame: At time of organ recovery ] [ Designated as safety issue: No ]
- Number of organs transplanted per donor [ Time Frame: Within 24 hours of organ recovery ] [ Designated as safety issue: No ]
- Organ Specific Outcomes [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ] [ Designated as safety issue: No ]Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, LFTs, P:F ratios, Lung Compliance, Cardiac biomarkers, EF from 2d Echo
- Pulsatile perfusion parameters [ Time Frame: Up to 24 hours of machine perfusion ] [ Designated as safety issue: No ]Perfusate flow and resistance in machine perfused kidneys.
- Six month hospital free survival of all organ recipients [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]
- Delayed Graft function (DGF) of Kidney recipients. [ Time Frame: 7 days post-transplant ] [ Designated as safety issue: No ]DGF is defined as the need for dialysis within the first week post transplantation.
|Study Start Date:||July 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
No Intervention: No RIPC
The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
Other: RIPC (Remote Ischemic Preconditioning)
Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515072
|United States, New Jersey|
|Rutgers, The State University of New Jersey|
|Newark, New Jersey, United States, 07101|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Baburao Koneru, MD||University of Medicine and Dentistry New Jersey-Newark|
|Principal Investigator:||William K Washburn, MD||University of Texas Health Sciences at San Antonio|