Candilio 2015.
| Methods |
Study design: RCT Total duration of study: 19 months, December 2010 ‐ July 2012 Setting: single‐centre study, Cardiovascular Institute, University College London, UK Withdrawals: 2 study subjects excluded from data analysis, no reason given |
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| Participants |
N = 180, (control = 90, intervention = 90) participants randomised Mean age = 66 years (± 10 years) Gender: 78% male; 22% female Severity of condition: CABG = 73%, valve surgery = 23%; single to quadruple vessel disease, EF > 50% = 77%, EF 30‐50% = 18.5%, EF < 30% = 4.5%, history of diabetes = 29.5%, recent MI = 29%, NYHA 0 = 9%, NYHA I = 31%, NYHA II = 45%, NYHA III = 14%, NYHA IV = 1% Inclusion criteria: adults (> 18 years of age) undergoing on‐pump CABG and/or valve surgery Exclusion criteria: cardiogenic shock or cardiac arrest in the current hospital admission, positive baseline serum hsTnT, pregnancy, significant peripheral arterial disease affecting upper and/or lower limbs, significant hepatic (INR > 2.0), pulmonary (forced expiratory volume‐1 < 40% predicted) or renal disease (estimated glomerular filtration rate < 30 mL/min/1.73 m2), and concomitant therapy with glibenclamide or nicorandil Reported differences between intervention and comparison groups: no statistical difference between groups with regard to baseline characteristics. With regards to treatments during surgery, participants in the control group received intravenous glyceryl trinitrate more often than those from the intervention group (76% vs 60%) Anaesthestetic gas used: isoflurane, sevoflurane, propofol |
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| Interventions |
Intervention: RIPC was delivered with 2 standard blood pressure cuffs, 1 placed on the upper arm and another placed on the upper thigh. Two cycles of RIPC (occluding pressure in cuff: 200 mmHg or 15 mmHg above systolic blood pressure) for 5 min, alternated with in‐between rest periods of 5 min after induction of anaesthesia Comparison: 2 cuffs were placed on the upper arm and upper thigh and left uninflated for 20 min Concomitant medications: aspirin = 80%, clopidogrel = 29.5%, warfarin = 8.5%, ß‐blocker = 64.5%, ca‐blocker = 31.5%, statin = 83.5%, ACE inhibitor = 68%, long‐acting nitrates = 15%, diuretics = 33.5% Excluded medications: glibenclamide or nicorandil |
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| Outcomes |
Outcomes and time points measured in the study: Perioperative MI, assessed by measuring the total 72‐h AUC hsTnT Blood samples for hsTnT preoperatively and 6 h, 12 h, 24 h, 48 h and 72 h postoperatively AKI score (serum creatinine and urine output measured preoperatively and 24 h, 48 h and 72 h postoperatively) Inotrope requirements (measured every 24 h over the 72‐h postoperative period as dosages mg/kg/min) Length of ICU and hospital stay (days) Incidence of postoperative atrial fibrillation within 72 h postoperatively Major adverse cardiovascular events at 6 weeks postoperatively (death, non‐fatal MI, coronary artery revascularisation and stroke) |
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| Notes |
Funding for trial: study was funded by the British Heart Foundation (grant numbers RG/03/007 and FS/10/039/28270), the Rosetrees Trust and supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre Notable conflicts of interest of authors: none to declare |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computer‐generated list of randomised numbers." |
| Allocation concealment (selection bias) | Low risk | "Sequentially numbered opaque sealed envelopes." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Randomisation, treatment allocation and delivery of RIPC or control protocols were performed by an unblinded investigator not involved in data collection or analysis. The investigator collecting and analysing the data, patients, cardiac surgeons and anaesthetists, operating theatre staff and staff on intensive care unit (ICU) and cardiac wards were all blinded to treatment allocation." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The investigator collecting and analysing the data, patients, cardiac surgeons and anaesthetists, operating theatre staff and staff on intensive care unit (ICU) and cardiac wards were all blinded to treatment allocation." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 180 participants were enrolled in the study. No lost‐to‐follow‐up or discontinued intervention described in the study flow chart. However, only 178 participants were included in the final analysis, the reason for excluding two participants missing |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods section were adequately reported or explained in results. |
| Other bias | Low risk | No other bias identified |