Dataset Information

Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial.

ABSTRACT:

Introduction

CORONARY is a large international randomised controlled trial comparing coronary artery bypass graft (CABG) surgery done with and without a bypass pump. Compared with on-pump, off-pump surgery may prevent acute kidney injury (AKI) in the short term and may better preserve kidney function 1 year following surgery. Secondary analyses may also clarify whether effects are similar in patients with and without pre-operative chronic kidney disease and whether AKI avoidance mediates preserved 1-year kidney function.

Methods and analysis

With respect to the study schedule, the last of 4752 patients from 79 sites in 19 countries were randomised in November 2011 to cardiac surgery performed with an on-pump or off-pump procedure. The authors will use regression models to compare the groups in the outcome of peri-operative AKI (per cent change in serum creatinine, ?50% increase in serum creatinine) and 1-year kidney function (per cent change in estimated glomerular filtration rate (eGFR), ?20% eGFR loss 1 year after surgery). The authors will use interaction terms in regression models to determine if there is a differential impact of the intervention in those with and without pre-existing chronic kidney disease. The authors will use regression-based tests to determine the proportion of the total effect of surgery type (off-pump vs on-pump CABG) on 1-year eGFR that is mediated by peri-operative AKI.

Ethics and dissemination

In the year 2009, the authors were competitively awarded a grant from the Canadian Institutes of Health Research to answer these kidney questions in CORONARY. Ethics approval was obtained for additional renal data collection in centres that agreed to study participation (>90% of participating centres). This collection began for patients enrolled after 1 January 2010. Remaining 1-year renal outcome data will be collected throughout 2012. Results will be reported in 2013.

Clinical trial registration number

NCT 00463294.

SUBMITTER: Garg AX

PROVIDER: S-EPMC3332245 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Publications

Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial.

Garg Amit X AX Devereaux P J PJ Yusuf Salim S Cuerden Meaghan S MS Parikh Chirag R CR Coca Steven G SG Walsh Michael M Cook Richard J RJ Whitlock Richard P RP Noiseux Nicolas N Novick Richard J RJ Ou Yongning Y Lamy Andre A

BMJ open 20120418 2

<h4>Introduction</h4>CORONARY is a large international randomised controlled trial comparing coronary artery bypass graft (CABG) surgery done with and without a bypass pump. Compared with on-pump, off-pump surgery may prevent acute kidney injury (AKI) in the short term and may better preserve kidney function 1 year following surgery. Secondary analyses may also clarify whether effects are similar in patients with and without pre-operative chronic kidney disease and whether AKI avoidance mediates ...[more]

PMID: 22514244

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Project description:BackgroundThe discontinuation of mechanical ventilation after coronary surgery may prolong and significantly increase the load on intensive care unit personnel. We hypothesized that automated mode using INTELLiVENT-ASV can decrease duration of postoperative mechanical ventilation, reduce workload on medical staff, and provide safe ventilation after off-pump coronary artery bypass grafting (OPCAB). The primary endpoint of our study was to assess the duration of postoperative mechanical ventilation during different modes of weaning from respiratory support (RS) after OPCAB. The secondary endpoint was to assess safety of the automated weaning mode and the number of manual interventions to the ventilator settings during the weaning process in comparison with the protocolized weaning mode.Materials and methodsForty adult patients undergoing elective OPCAB were enrolled into a prospective single-center study. Patients were randomized into two groups: automated weaning (n = 20) using INTELLiVENT-ASV mode with quick-wean option; and protocolized weaning (n = 20), using conventional synchronized intermittent mandatory ventilation (SIMV) + pressure support (PS) mode. We assessed the duration of postoperative ventilation, incidence and duration of unacceptable RS, and the load on medical staff. We also performed the retrospective analysis of 102 patients (standard weaning) who were weaned from ventilator with SIMV + PS mode based on physician's experience without prearranged algorithm.Results and discussionRealization of the automated weaning protocol required change in respiratory settings in 2 patients vs. 7 (5-9) adjustments per patient in the protocolized weaning group. Both incidence and duration of unacceptable RS were reduced significantly by means of the automated weaning approach. The FiO2 during spontaneous breathing trials was significantly lower in the automated weaning group: 30 (30-35) vs. 40 (40-45) % in the protocolized weaning group (p < 0.01). The average time until tracheal extubation did not differ in the automated weaning and the protocolized weaning groups: 193 (115-309) and 197 (158-253) min, respectively, but increased to 290 (210-411) min in the standard weaning group.ConclusionThe automated weaning system after off-pump coronary surgery might provide postoperative ventilation in a more protective way, reduces the workload on medical staff, and does not prolong the duration of weaning from ventilator. The use of automated or protocolized weaning can reduce the duration of postoperative mechanical ventilation in comparison with non-protocolized weaning based on the physician's decision.

Dataset Information

Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Clinical trial registration number

Publications

Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial.

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