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

Sponsor:	University of Aarhus
Collaborators:	Sahlgrenska University Hospital, Sweden Lundbeck Foundation Novo Nordisk
Information provided by (Responsible Party):	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01395719

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:

MedlinePlus related topics: Kidney Transplantation

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:	September 2013
Estimated Primary Completion Date:	September 2013 (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

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

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:	March 5, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Ethics Committee

Keywords provided by University of Aarhus:

renal transplantation
glomerular filtration rate
ischemic preconditioning
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, 2012