Overview

This trial is active, not recruiting.

Conditions kidney transplantation, delayed graft function, acute kidney injury, glomerular filtration rate
Treatment remote ischemic conditioning
Sponsor University of Aarhus
Collaborator Sahlgrenska University Hospital, Sweden
Start date June 2011
End date June 2015
Trial size 220 participants
Trial identifier NCT01395719, 121369

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(No Intervention)
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)
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.
remote ischemic conditioning Remote ischemic preconditioning
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.

Primary Outcomes

Measure
Time to a 50% drop in baseline plasma-creatinine
time frame: minimum 1 week

Secondary Outcomes

Measure
Need for dialysis
time frame: 1 week
GFR after 1 year
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
Principal investigator Nicoline V Krogstrup, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.