Advanced

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

Ederoth, Per LU ; Grins, Edgars LU ; Dardashti, Alain LU ; Brondén, Björn LU ; Metzsch, Carsten LU ; Erdling, André LU ; Nozohoor, Shahab LU ; Mokhtari, Arash LU ; Hansson, Magnus J. LU and Elmér, Eskil LU , et al. (2016) In BMJ Open 6(12).
Abstract

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,... (More)

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.

(Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
BMJ Open
volume
6
issue
12
publisher
British Medical Journal Publishing Group
external identifiers
  • scopus:85007018311
  • wos:000391303600040
ISSN
2044-6055
DOI
10.1136/bmjopen-2016-012299
language
English
LU publication?
yes
id
39451481-13ad-40b4-ac84-68e4f05f638f
date added to LUP
2017-01-13 09:32:07
date last changed
2017-09-18 11:31:16
@article{39451481-13ad-40b4-ac84-68e4f05f638f,
  abstract     = {<p>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.</p>},
  articleno    = {bmjopen-2016-012299},
  author       = {Ederoth, Per and Grins, Edgars and Dardashti, Alain and Brondén, Björn and Metzsch, Carsten and Erdling, André and Nozohoor, Shahab and Mokhtari, Arash and Hansson, Magnus J. and Elmér, Eskil and Algotsson, Lars and Jovinge, Stefan and Bjursten, Henrik},
  issn         = {2044-6055},
  language     = {eng},
  month        = {12},
  number       = {12},
  publisher    = {British Medical Journal Publishing Group},
  series       = {BMJ Open},
  title        = {Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS) : A study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study},
  url          = {http://dx.doi.org/10.1136/bmjopen-2016-012299},
  volume       = {6},
  year         = {2016},
}