Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function (Context)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|