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

Primary Purpose

Kidney Transplantation, Delayed Graft Function, Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Transplantation focused on measuring renal transplantation, glomerular filtration rate, remote ischemic preconditioning, remote ischemic conditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. of Renal Medicine, Aarhus University Hospital, Skejby
  • University Medical Center Groningen
  • Division of Transplant Surgery, Erasmus MC, University Medical Center
  • Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non remote ischemic conditionin(non-rIC)

Remote ischemic conditioning (rIC)

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Need for dialysis
GFR after 1 year
GFR measurement by Cr-EDTA.

Full Information

First Posted
July 14, 2011
Last Updated
August 17, 2015
Sponsor
University of Aarhus
Collaborators
Sahlgrenska University Hospital, Sweden, Lundbeck Foundation, Novo Nordisk A/S, AP Moeller Foundation, Danish Society of Nephrology, Aarhus University Hospital, Erasmus Medical Center, University Medical Center Groningen, Danish Council for Independent Research
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1. Study Identification

Unique Protocol Identification Number
NCT01395719
Brief Title
Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
Acronym
Context
Official Title
Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Sahlgrenska University Hospital, Sweden, Lundbeck Foundation, Novo Nordisk A/S, AP Moeller Foundation, Danish Society of Nephrology, Aarhus University Hospital, Erasmus Medical Center, University Medical Center Groningen, Danish Council for Independent Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Delayed Graft Function, Acute Kidney Injury, Glomerular Filtration Rate
Keywords
renal transplantation, glomerular filtration rate, remote ischemic preconditioning, remote ischemic conditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non remote ischemic conditionin(non-rIC)
Arm Type
No Intervention
Arm 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).
Arm Title
Remote ischemic conditioning (rIC)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Remote ischemic conditioning
Other Intervention Name(s)
Remote ischemic preconditioning, Ischemic conditioning
Intervention Description
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 Outcome Measure Information:
Title
Time to a 50% drop in baseline plasma-creatinine
Description
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.
Time Frame
minimum 1 week
Secondary Outcome Measure Information:
Title
Need for dialysis
Time Frame
1 week
Title
GFR after 1 year
Description
GFR measurement by Cr-EDTA.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 If donor is a small child If the patient receives a double transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicoline V Krogstrup, MD
Organizational Affiliation
Klinisk Institut, Aarhus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bente Jespersen, Professor, DMSc, MD
Organizational Affiliation
Klinisk Institut, Aarhus University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Henrik Birn, DMSc, MD
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mihai Oltean, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gertrude J. Nieuwenhuijs-Moeke, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Frank J. M. F. Dor, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Renal Medicine, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Division of Transplant Surgery, Erasmus MC, University Medical Center
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34473350
Citation
Nielsen MB, Ravlo K, Eijken M, Krogstrup NV, Bue Svendsen M, Abdel-Halim C, Steen Petersen M, Birn H, Oltean M, Jespersen B, Moller BK. Dynamics of circulating dendritic cells and cytokines after kidney transplantation-No effect of remote ischaemic conditioning. Clin Exp Immunol. 2021 Nov;206(2):226-236. doi: 10.1111/cei.13658. Epub 2021 Sep 29.
Results Reference
derived
PubMed Identifier
34379701
Citation
Nielsen MB, Jespersen B, Birn H, Krogstrup NV, Bourgonje AR, Leuvenink HGD, van Goor H, Norregaard R. Elevated plasma free thiols are associated with early and one-year graft function in renal transplant recipients. PLoS One. 2021 Aug 11;16(8):e0255930. doi: 10.1371/journal.pone.0255930. eCollection 2021.
Results Reference
derived
PubMed Identifier
31887168
Citation
Nielsen MB, Krogstrup NV, Oltean M, Nieuwenhuijs-Moeke GJ, Dor FJMF, Birn H, Jespersen B. Remote ischaemic conditioning and early changes in plasma creatinine as markers of one year kidney graft function-A follow-up of the CONTEXT study. PLoS One. 2019 Dec 30;14(12):e0226882. doi: 10.1371/journal.pone.0226882. eCollection 2019.
Results Reference
derived
PubMed Identifier
30817778
Citation
Nielsen MB, Krogstrup NV, Nieuwenhuijs-Moeke GJ, Oltean M, Dor FJMF, Jespersen B, Birn H. P-NGAL Day 1 predicts early but not one year graft function following deceased donor kidney transplantation - The CONTEXT study. PLoS One. 2019 Feb 28;14(2):e0212676. doi: 10.1371/journal.pone.0212676. eCollection 2019.
Results Reference
derived
PubMed Identifier
27696662
Citation
Krogstrup NV, Oltean M, Nieuwenhuijs-Moeke GJ, Dor FJ, Moldrup U, Krag SP, Bibby BM, Birn H, Jespersen B. Remote Ischemic Conditioning on Recipients of Deceased Renal Transplants Does Not Improve Early Graft Function: A Multicenter Randomized, Controlled Clinical Trial. Am J Transplant. 2017 Apr;17(4):1042-1049. doi: 10.1111/ajt.14075. Epub 2016 Nov 9.
Results Reference
derived
PubMed Identifier
26297360
Citation
Krogstrup NV, Oltean M, Bibby BM, Nieuwenhuijs-Moeke GJ, Dor FJ, Birn H, Jespersen B. Remote ischaemic conditioning on recipients of deceased renal transplants, effect on immediate and extended kidney graft function: a multicentre, randomised controlled trial protocol (CONTEXT). BMJ Open. 2015 Aug 20;5(8):e007941. doi: 10.1136/bmjopen-2015-007941.
Results Reference
derived

Learn more about this trial

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

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