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

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Lundbeck Foundation
Novo Nordisk
Institute of Clinical Medicine, Aarhus University
AP Moeller Foundation
Danish Society of Nephrology
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01395719
First received: July 14, 2011
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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


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: 200
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)
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395719

Contacts
Contact: Nicoline V Krogstrup, MD 45 61268123 nicoline.v.krogstrup@ki.au.dk
Contact: Bente Jespersen, Prof., DMSc, MD 45 89495704 bjesper@dadlnet.dk

Locations
Denmark
Dept. of Renal Medicine, Aarhus University Hospital, Skejby Recruiting
Aarhus N, Denmark, 8200
Contact: Bente Jespersen, Professor, DMSc, MD     45 89495704     bjesper@dadlnet.dk    
Principal Investigator: Nicoline V Korgstrup, MD, PhD fellow            
Sweden
Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg Recruiting
Gothenburg, Sweden, 413 45
Contact: Mihai Oltean, MD, PhD         mihai.oltean@surgery.gu.se    
Principal Investigator: Mihai Oltean, MD, PhD            
Sponsors and Collaborators
University of Aarhus
Sahlgrenska University Hospital, Sweden
Lundbeck Foundation
Novo Nordisk
Institute of Clinical Medicine, Aarhus University
AP Moeller Foundation
Danish Society of Nephrology
Aarhus University Hospital
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
  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: November 6, 2012
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:
Ischemia
Acute Kidney Injury
Delayed Graft Function
Pathologic Processes
 Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013