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

Acute Kidney Injury Clinical Trial

— Context  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01395719
• Other study ID #: 121369
• Status: Active, not recruiting
• Phase: N/A
• First received: July 14, 2011
• Last updated: August 17, 2015
• Start date: June 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Delayed Graft Function
• Glomerular Filtration Rate
• Kidney Transplantation

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dept. of Renal Medicine, Aarhus University Hospital, Skejby	Aarhus N
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Division of Transplant Surgery, Erasmus MC, University Medical Center	Rotterdam
Sweden	Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg	Gothenburg

Sponsors (10)

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

Countries where clinical trial is conducted

Denmark,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to a 50% drop in baseline plasma-creatinine	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	No
Secondary	Need for dialysis		1 week	No
Secondary	GFR after 1 year	GFR measurement by Cr-EDTA.	12 months	No