Clinical trial NCT01395719: Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
Official title: Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Delayed Graft Function
Acute Kidney Injury
Glomerular Filtration Rate
Keywords: renal transplantation
glomerular filtration rate
remote ischemic preconditioning
remote ischemic conditioning
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Lundbeck Foundation
name: Novo Nordisk A/S
name: AP Moeller Foundation
name: Danish Society of Nephrology
name: Aarhus University Hospital
name: Erasmus Medical Center
name: University Medical Center Groningen
name: Danish Council for Independent Research
First posted: 2011-07-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Time to a 50% drop in baseline plasma-creatinine
timeFrame: minimum 1 week
Secondary outcomes:
measure: Need for dialysis
timeFrame: 1 week
measure: GFR after 1 year
timeFrame: 12 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Dept. of Renal Medicine, Aarhus University Hospital, Skejby
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Rotterdam
country: Netherlands
facility: Division of Transplant Surgery, Erasmus MC, University Medical Center
city: Gothenburg
country: Sweden
facility: Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg
Study officials:
affiliation: Klinisk Institut, Aarhus University
name: Nicoline V Krogstrup, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinisk Institut, Aarhus University
name: Bente Jespersen, Professor, DMSc, MD
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Henrik Birn, DMSc, MD
role: STUDY_CHAIR
affiliation: Sahlgrenska University Hospital
name: Mihai Oltean, MD, PhD
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: Gertrude J. Nieuwenhuijs-Moeke, MD
role: STUDY_CHAIR
affiliation: Erasmus Medical Center
name: Frank J. M. F. Dor, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.