Acute Kidney Injury Clinical Trial
Official title:
Ciclosporin to Protect Renal Function In Cardiac Surgery: CiPRICS A Phase II Double Blind Randomized Placebo Controlled Study
The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and degree of acute kidney injury after cardiac surgery.
Acute kidney injury (AKI) is a common complication after cardiac surgery and is associated
with decreased long-term survival. The mechanism for inducing acute kidney injury is unknown
but ischaemia-reperfusion injury is indicated to be a part of the cause.
Animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of
ciclosporin in ischaemia-reperfusion injury in the kidney. The major mechanism is thought to
be inhibition of the reperfusion triggered opening of the mitochondrial permeability
transition pore (mPTP), responsible for reperfusion-induced necrosis. During cardiac
surgery, the period of extracorporeal circulation (ECC) changes the perfusion through the
kidney. Return to normal perfusion with a beating heart has similarities with reperfusion
following ischemia.
Administration of ciclosporin in conjunction with percutaneous coronary intervention (PCI),
heart surgery and traumatic brain injury (TBI) in humans has shown to be safe with no direct
side-effects.
The investigators therefore hypothesize that a preconditioning effect of ciclosporin before
coronary artery bypass grafting (CABG) can reduce the level of renal dysfunction after this
type of cardiac surgery.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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