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

University of Aarhus

Status: Unknown

Conditions: Glomerular Filtration Rate; Kidney Transplantation; Acute Kidney Injury; Delayed Graft Function

Treatments: Other: Remote ischemic conditioning

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01395719

121369

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Non remote ischemic conditionin(non-rIC)

No Intervention group

Description:

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).

Remote ischemic conditioning (rIC)

Experimental group

Description:

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.

Treatment:

Other: Remote ischemic conditioning