Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)
ConditionTransplant Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital
About this trial
Remote ischemic preconditioning (RIPC) is a concept where remotely induced ischemia produces protection against ischemia-reperfusion injury in a remote organ. RIPC has been studied extensively in animal models and heart surgery, but it's benefit in transplantation has been studied less. The primary aim of this study is to find out whether RIPC performed in a donor in donation after brain-death (DBD) could improve delayed graft function rate of kidney transplants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Brain-dead organ donor with a plan of harvesting at least one kidney
Disqualifiers
Haemodynamically unstable donor
Age below 18 years
Planned organ recipients are recruited to another prospective trial, which prevents participation in this trial.
Trial design
Design model
Parallel
Treatments tested in this trial
RIPC
Procedure/SurgeryRemote Ischaemic Preconditioning
Sham-RIPC
Procedure/SurgerySham procedure
Treatment groups
496 Participants
are divided into 2 treatment groupsGroup A: RIPCExperimental treatment 1 intervention
Group B: Sham-RIPCSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
DGF
Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
Time frame
7 daysSecondary outcomes
1
Kidney allografts: eGFR
Kidney allografts: estimated glomerular filtration rate
Time frame
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year2
Combined Pancreas-Kidney allografts: eGFR
Combined Pancreas-Kidney allografts: estimated glomerular filtration rate
Time frame
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year3
Kidney allografts: BPAR
Kidney allografts: Biopsy proven acute rejection
Time frame
within 1 year4
Combined Pancreas-Kidney allografts: Kidney BPAR
Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft
Time frame
within 1 yearOther outcomes
1
Exploratory outcomes Kidney allograft miR-21
Measurement of reperfusion injury in blood and urine samples micro-RNA miR-21
Time frame
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion2
Exploratory outcomes Kidney allograft miR-24
Measurement of reperfusion injury in blood and urine samples micro-RNA miR-24
Time frame
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion3
Exploratory outcomes Kidney allograft NGAL
Measurement of reperfusion injury in blood and urine samples neutrophil gelatinase associated lipocain NGAL
Time frame
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion4
Exploratory outcomes Kidney allograft KIM-1
Measurement of reperfusion injury in blood and urine samples kidney injury molecule -1 KIM-1
Time frame
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helsinki University Central Hospital
Lead sponsor
Finska Läkaresällskapet (funding)
Collaborator
Academy of Finland
Collaborator
Helsinki University Hospital Research Funds (funding)
Collaborator
Source ClinicalTrials.gov