Acute Kidney Injury Clinical Trial
— ContextOfficial title:
Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
The purpose of this study is to determine whether remote ischemic conditioning can improve the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is performed on the patient receiving a kidney from a deceased donor. Remote ischemic conditioning is done during the operation by inflating a tourniquet on the patients leg before opening the blood circulation to the kidney. The study focus on both the immediate kidney function after the transplantation, but also on the extended kidney function one year after the transplantation.
Status | Active, not recruiting |
Enrollment | 220 |
Est. completion date | June 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 and above - Received information, signed consent - Candidate for kidney transplantation from deceased donor Exclusion Criteria: - Can't give informed consent - AV-fistula in the leg opposite the site where the graft will be placed - Threatening ischemia in the leg - If donor is a small child - If the patient receives a double transplant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Renal Medicine, Aarhus University Hospital, Skejby | Aarhus N | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Division of Transplant Surgery, Erasmus MC, University Medical Center | Rotterdam | |
Sweden | Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, AP Moeller Foundation, Danish Council for Independent Research, Danish Society of Nephrology, Erasmus Medical Center, Lundbeck Foundation, Novo Nordisk A/S, Sahlgrenska University Hospital, Sweden, University Medical Center Groningen |
Denmark, Netherlands, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to a 50% drop in baseline plasma-creatinine | Plasma-creatinine changes posttransplant will be described using an exponential/logistic/linear model depending on the individual patient data. All plasma-creatinine values 30 days posttransplant, or in case of temporary posttransplant dialysis 30 days after the last performed dialysis, will be used, measured minimum twice daily initially. Baseline plasma-creatinine is measured approximately 1 hour prior to reperfusion of the kidney. Time to a 50% drop in baseline plasma-creatinine will be estimated. | minimum 1 week | No |
Secondary | Need for dialysis | 1 week | No | |
Secondary | GFR after 1 year | GFR measurement by Cr-EDTA. | 12 months | No |
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