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

August 17, 2015 updated by: University of Aarhus
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Dept. of Renal Medicine, Aarhus University Hospital, Skejby
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Rotterdam, Netherlands, 3000 CA
        • Division of Transplant Surgery, Erasmus MC, University Medical Center
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
minimum 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for dialysis
Time Frame: 1 week
1 week
GFR after 1 year
Time Frame: 12 months
GFR measurement by Cr-EDTA.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Novo Nordisk A/S
Aarhus University Hospital
University Medical Center Groningen
Erasmus Medical Center
Sahlgrenska University Hospital, Sweden
Lundbeck Foundation
Danish Council for Independent Research
AP Moeller Foundation
Danish Society of Nephrology

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (ESTIMATE)

July 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplantation

Clinical Trials on Remote ischemic conditioning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe