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

NCT01395719 | Unknown

• 1 other identifier: 121369
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 4

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Need for dialysis

  1 week

• GFR after 1 year

  12 months

Study Arms (2)

Non remote ischemic conditionin(non-rIC)

NO INTERVENTION

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).

Remote ischemic conditioning (rIC)

EXPERIMENTAL

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

Interventions

Remote ischemic conditioning OTHER

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.

Also known as: Remote ischemic preconditioning, Ischemic conditioning

Remote ischemic conditioning (rIC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Received information, signed consent
• Candidate for kidney transplantation from deceased donor

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Sahlgrenska University Hospital: collaborator
• Lundbeck Foundation: collaborator
• Novo Nordisk A/S: collaborator
• AP Moeller Foundation: collaborator
• Danish Society of Nephrology: collaborator
• Aarhus University Hospital: collaborator
• Erasmus Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Danish Council for Independent Research: collaborator

Study Sites (4)

Dept. of Renal Medicine, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Division of Transplant Surgery, Erasmus MC, University Medical Center

Rotterdam, Rotterdam, 3000 CA, Netherlands

Location

Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg

Gothenburg, 413 45, Sweden

Location

Related Publications (6)

• 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.

  PMID: 34473350 DERIVED

• 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.

  PMID: 34379701 DERIVED

• 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.

  PMID: 31887168 DERIVED

• 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.

  PMID: 30817778 DERIVED

• 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.

  PMID: 27696662 DERIVED

• 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.

  PMID: 26297360 DERIVED

MeSH Terms

Conditions

Delayed Graft Function; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nicoline V Krogstrup, MD

  Klinisk Institut, Aarhus University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

• Gertrude J. Nieuwenhuijs-Moeke, MD

  University Medical Center Groningen

  STUDY CHAIR

• Frank J. M. F. Dor, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 15, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

DK (1); NL (2); SE (1)