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

NCT01395719 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2015-08-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER
  • Lundbeck Foundation

    collaborator OTHER
  • Novo Nordisk A/S

    collaborator INDUSTRY
  • AP Moeller Foundation

    collaborator OTHER
  • Danish Society of Nephrology

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • University Medical Center Groningen

    collaborator OTHER
  • Danish Council for Independent Research

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Nicoline V Krogstrup, MD · Klinisk Institut, Aarhus University

  • Bente Jespersen, Professor, DMSc, MD · Klinisk Institut, Aarhus University

  • Henrik Birn, DMSc, MD · University of Aarhus

  • Mihai Oltean, MD, PhD · Sahlgrenska University Hospital

  • Gertrude J. Nieuwenhuijs-Moeke, MD · University Medical Center Groningen

  • Frank J. M. F. Dor, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • Denmark
  • Netherlands
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395719 on ClinicalTrials.gov