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.
Delayed Graft Function
Acute Kidney Injury
Glomerular Filtration Rate
Other: Remote ischemic conditioning
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function|
- Time to a 50% drop in baseline plasma-creatinine [ Time Frame: minimum 1 week ] [ Designated as safety issue: No ]The time dependent plasma-creatinine changes will be described using an exponential/logistic/linear model depending on the individual patient data. All available plasma-creatinine values after transplantation until steady state is achieved 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 calculated.
- Need for dialysis [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- GFR after 1 year [ Time Frame: 12 months ] [ Designated as safety issue: No ]GFR measurement by Cr-EDTA.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
No Intervention: Non remote ischemic conditionin(non-rIC)
Patients receiving kidney transplantation from a deceased donor. This group does not receive remote ischemic conditioning, but has a tourniquet on the leg (not inflated).
Experimental: Remote ischemic conditioning (rIC)
Patients receiving kidney transplantation from a deceased donor. This group receives remote ischemic conditioning by inflating a tourniquet on the leg during surgery, before reperfusion of the kidney.
Other: Remote ischemic conditioning
Patients receiving kidney transplantation from a deceased donor. Remote ischemic conditioning (rIC) is done by inflating a tourniquet (250mmHg) on the patients leg before reperfusion of the kidney. The tourniquet stays on the leg on the opposite site of were the kidney is placed. rIC is done 4 x 5 min with 5 min intervals between with free blood flow.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395719
|Dept. of Renal Medicine, Aarhus University Hospital, Skejby|
|Aarhus N, Denmark, 8200|
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 GZ|
|Division of Transplant Surgery, Erasmus MC, University Medical Center|
|Rotterdam, Netherlands, 3000 CA|
|Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg|
|Gothenburg, Sweden, 413 45|
|Principal Investigator:||Nicoline V Krogstrup, MD||Klinisk Institut, Aarhus University|
|Study Chair:||Bente Jespersen, Professor, DMSc, MD||Klinisk Institut, Aarhus University|
|Study Chair:||Henrik Birn, DMSc, MD||University of Aarhus|
|Study Chair:||Mihai Oltean, MD, PhD||Sahlgrenska University Hospital, Sweden|
|Study Chair:||Gertrude J. Nieuwenhuijs-Moeke, MD||University Medical Centre Groningen|
|Study Chair:||Frank J. M. F. Dor, MD, PhD||Erasmus Medical Center|