Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
NCT ID: NCT01395719
Last Updated: 2015-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2011-06-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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).
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received information, signed consent
* Candidate for kidney transplantation from deceased donor
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Lundbeck Foundation
OTHER
Novo Nordisk A/S
INDUSTRY
AP Moeller Foundation
OTHER
Danish Society of Nephrology
OTHER
Aarhus University Hospital
OTHER
Erasmus Medical Center
OTHER
University Medical Center Groningen
OTHER
Danish Council for Independent Research
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Nicoline V Krogstrup, MD
Role: PRINCIPAL_INVESTIGATOR
Klinisk Institut, Aarhus University
Bente Jespersen, Professor, DMSc, MD
Role: STUDY_CHAIR
Klinisk Institut, Aarhus University
Henrik Birn, DMSc, MD
Role: STUDY_CHAIR
University of Aarhus
Mihai Oltean, MD, PhD
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Gertrude J. Nieuwenhuijs-Moeke, MD
Role: STUDY_CHAIR
University Medical Center Groningen
Frank J. M. F. Dor, MD, PhD
Role: STUDY_CHAIR
Erasmus Medical Center
Locations
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Dept. of Renal Medicine, Aarhus University Hospital, Skejby
Aarhus N, , Denmark
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Division of Transplant Surgery, Erasmus MC, University Medical Center
Rotterdam, Rotterdam, Netherlands
Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg
Gothenburg, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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121369
Identifier Type: -
Identifier Source: org_study_id
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