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

Conditions

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

Keywords

renal transplantation, glomerular filtration rate, remote ischemic preconditioning, remote ischemic conditioning

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.

Nielsen MB, Krogstrup NV, Sørensen MV, Kristensen AM, CONTEXT Study Group*, Schiessl IM, Leipziger J, Birn H, Berg P.

2026-07-24

10.1007/s00424-026-03198-5

Elevated plasma free thiols are associated with early and one-year graft function in renal transplant recipients

Marie Bodilsen Nielsen, Bente Jespersen, Henrik Birn, Nicoline V. Krogstrup, Arno R. Bourgonje et al. (8 authors)

PLoS ONE2021-08-118 citations

10.1371/journal.pone.0255930

Remote ischaemic conditioning and early changes in plasma creatinine as markers of one year kidney graft function—A follow-up of the CONTEXT study

Marie Bodilsen Nielsen, Nicoline V. Krogstrup, Mihai Oltean, Gertrude J. Nieuwenhuijs‐Moeke, Frank J. M. F. Dor et al. (7 authors)

PLoS ONE2019-12-3023 citations

10.1371/journal.pone.0226882

P-NGAL Day 1 predicts early but not one year graft function following deceased donor kidney transplantation – The CONTEXT study

Marie Bodilsen Nielsen, Nicoline V. Krogstrup, Gertrude J. Nieuwenhuijs‐Moeke, Mihai Oltean, Frank J. M. F. Dor et al. (7 authors)

PLoS ONE2019-02-2817 citations

10.1371/journal.pone.0212676

Remote Ischemic Conditioning on Recipients of Deceased Renal Transplants Does Not Improve Early Graft Function: A Multicenter Randomized, Controlled Clinical Trial.

Krogstrup NV, Oltean M, Nieuwenhuijs-Moeke GJ, Dor FJ, Møldrup U, Krag SP, Bibby BM, Birn H, Jespersen B.

2016-11-0938 citations

10.1111/ajt.14075

Remote ischaemic conditioning on recipients of deceased renal transplants, effect on immediate and extended kidney graft function: a multicentre, randomised controlled trial protocol (CONTEXT)

Nicoline V. Krogstrup, Mihai Oltean, Bo Martin Bibby, Gertrude J. Nieuwenhuijs‐Moeke, Frank J. M. F. Dor et al. (7 authors)

BMJ Open2015-08-0120 citations

10.1136/bmjopen-2015-007941

Interventions

OTHERRemote 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Time to a 50% drop in baseline plasma-creatinine	minimum 1 week	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

Measure	Time frame	Description
Need for dialysis	1 week	—
GFR after 1 year	12 months	GFR measurement by Cr-EDTA.

Countries

Denmark, Netherlands, Sweden

Outcome results

None listed