Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Lundbeck Foundation
Novo Nordisk A/S
Institute of Clinical Medicine, Aarhus University
AP Moeller Foundation
Danish Society of Nephrology
Aarhus University Hospital
Erasmus Medical Center
University Medical Center Groningen
Danish Council for Independent Research
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01395719
First received: July 14, 2011
Last updated: August 17, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention
Kidney Transplantation
Delayed Graft Function
Acute Kidney Injury
Glomerular Filtration Rate
Other: Remote ischemic conditioning

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Time to a 50% drop in baseline plasma-creatinine [ Time Frame: minimum 1 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 220
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Remote ischemic preconditioning
  • Ischemic conditioning

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395719

Locations
Denmark
Dept. of Renal Medicine, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Division of Transplant Surgery, Erasmus MC, University Medical Center
Rotterdam, Netherlands, 3000 CA
Sweden
Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
University of Aarhus
Sahlgrenska University Hospital, Sweden
Lundbeck Foundation
Novo Nordisk A/S
Institute of Clinical Medicine, Aarhus University
AP Moeller Foundation
Danish Society of Nephrology
Aarhus University Hospital
Erasmus Medical Center
University Medical Center Groningen
Danish Council for Independent Research
Investigators
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01395719     History of Changes
Other Study ID Numbers: 121369
Study First Received: July 14, 2011
Last Updated: August 17, 2015
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
renal transplantation
glomerular filtration rate
remote ischemic preconditioning
remote ischemic conditioning

Additional relevant MeSH terms:
Acute Kidney Injury
Delayed Graft Function
Kidney Diseases
Pathologic Processes
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on August 31, 2015