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|
- The fall in creatinin the first week after transplantation [ Time Frame: 1 week ] [ Designated as safety issue: No ]A mathematical method will determine the speed of the decrease in plasma-creatinin
- 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:||May 2011|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2014 (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
|Contact: Nicoline V Krogstrup, MD||45 firstname.lastname@example.org|
|Contact: Bente Jespersen, Prof., DMSc, MD||45 email@example.com|
|Dept. of Renal Medicine, Aarhus University Hospital, Skejby||Recruiting|
|Aarhus N, Denmark, 8200|
|Contact: Bente Jespersen, Professor, DMSc, MD 45 89495704 firstname.lastname@example.org|
|Principal Investigator: Nicoline V Korgstrup, MD, PhD fellow|
|Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg||Recruiting|
|Gothenburg, Sweden, 413 45|
|Contact: Mihai Oltean, MD, PhD email@example.com|
|Principal Investigator: Mihai Oltean, MD, PhD|
|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|