Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS): a study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study

BMJ Open. 2016 Dec 15;6(12):e012299. doi: 10.1136/bmjopen-2016-012299.


Introduction: Acute kidney injury (AKI) after cardiac surgery is common and results in increased morbidity and mortality. One possible mechanism for AKI is ischaemia-reperfusion injury caused by the extracorporeal circulation (ECC), resulting in an opening of the mitochondrial permeability transition pore (mPTP) in the kidneys, which can lead to cell injury or cell death. Ciclosporin may block the opening of mPTP if administered before the ischaemia-reperfusion injury. We hypothesised that ciclosporin given before the start of ECC in cardiac surgery can decrease the degree of AKI.

Methods and analysis: Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS) study is an investigator-initiated double-blind, randomised, placebo-controlled, parallel design, single-centre study performed at a tertiary university hospital. The primary objective is to assess the safety and efficacy of ciclosporin to limit the degree of AKI in patients undergoing coronary artery bypass grafting surgery. We aim to evaluate 150 patients with a preoperative estimated glomerular filtration rate of 15-90 mL/min/1.73 m2. Study patients are randomised in a 1:1 ratio to receive study drug 2.5 mg/kg ciclosporin or placebo as an intravenous injection after anaesthesia induction but before start of surgery. The primary end point consists of relative P-cystatin C changes from the preoperative day to postoperative day 3. The primary variable will be tested using an analysis of covariance method. Secondary end points include evaluation of P-creatinine and biomarkers of kidney, heart and brain injury.

Ethics and dissemination: The trial is conducted in compliance with the current version of the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice guidelines E6 (R1) and was approved by the Regional Ethical Review Board, Lund and the Swedish Medical Products Agency (MPA). Written and oral informed consent is obtained before enrolment into the study.

Trial registration number: NCT02397213; Pre-results.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Acute Kidney Injury / drug therapy*
  • Acute Kidney Injury / etiology
  • Biomarkers
  • Coronary Artery Bypass / adverse effects*
  • Creatinine / blood
  • Cyclosporine / administration & dosage*
  • Double-Blind Method
  • Glomerular Filtration Rate / drug effects
  • Hospitals, University
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Kidney / drug effects
  • Kidney / physiopathology
  • Mitochondrial Membrane Transport Proteins / drug effects
  • Mitochondrial Permeability Transition Pore
  • Postoperative Complications / drug therapy*
  • Postoperative Complications / prevention & control
  • Preoperative Care / methods*
  • Proof of Concept Study
  • Reperfusion Injury / prevention & control
  • Research Design
  • Sweden


  • Biomarkers
  • Immunosuppressive Agents
  • Mitochondrial Membrane Transport Proteins
  • Mitochondrial Permeability Transition Pore
  • Cyclosporine
  • Creatinine

Associated data