Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function (Context)
|ClinicalTrials.gov Identifier: NCT01395719|
Recruitment Status : Unknown
Verified August 2015 by University of Aarhus.
Recruitment status was: Active, not recruiting
First Posted : July 15, 2011
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Delayed Graft Function Acute Kidney Injury Glomerular Filtration Rate||Other: Remote ischemic conditioning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2016|
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.
- Time to a 50% drop in baseline plasma-creatinine [ Time Frame: minimum 1 week ]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.
- Need for dialysis [ Time Frame: 1 week ]
- GFR after 1 year [ Time Frame: 12 months ]GFR measurement by Cr-EDTA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Center Groningen|
|Study Chair:||Frank J. M. F. Dor, MD, PhD||Erasmus Medical Center|