Wahby 2016.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: diabetic people planned for coronary artery bypass graft (CABG) surgery Exclusion criteria: emergency CABG, off‐pump surgery and combined valve and CABG surgery Diagnostic criteria: — Setting: Tanta University Hospital and National Heart Institute Age group: — Gender distribution: females and males Country where trial was performed: Egypt |
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| Interventions |
Intervention(s): tight glycaemic control during operation to maintain blood glucose level between 110 mg/dL and 149 mg/dL Comparator(s): conventional moderate glycaemic control to achieve blood glucose level between 150 mg/dL and 180 mg/dL during surgery Duration of intervention: perioperative Duration of follow‐up: 30 days after surgery Run‐in period: none Number of study centres: 1 Treatment before trial: — |
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| Outcomes | Reported outcome(s) in full text of publication: operative mortality (defined as mortality within 30 days of operation or during hospitalisation due to cause related to operation), renal dysfunction (elevated serum creatinine above 2 mg/dL postoperative or more than 25% of preoperative level), acute renal failure required postoperative dialysis, postoperative permanent neurological deficit, sternal wound infection, leg infection and need for postoperative inotropic support that was defined as the use of dopamine 5 mg/kg/min; any dose of epinephrine, norepinephrine, dobutamine or milrinone. All participants were followed up regarding duration of mechanical ventilation postoperatively. Prolonged mechanical ventilation was defined as cumulative duration of 24 h or more of endotracheal intubation starting from transfer of the participant to cardiac surgery ICU after completion of operation. The occurrence of postoperative atrial fibrillation (AF) and perioperative myocardial infarction were recorded. Perioperative myocardial infarction was defined as any participant having fresh ECG changes including new Q‐waves in two precordial leads, new bundle branch block, haemodynamic compromise with new segmental wall motion dysfunction or elevation of CK MB over 100 U/L after undergoing open heart surgery. | |
| Study registration |
Trial identifier: — Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: — Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote: "we aimed to detect the effect of perioperative tight glycaemic control versus moderate glycaemic control on the outcome of diabetic patients undergoing CABG surgery" | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Patients were randomly assigned into 2 groups according to computer allocated generation table (graph pad software)” |
| Allocation concealment (selection bias) | Unclear risk | Comment: described as randomised but no additional details provided about the sequence concealment |
| Blinding of participants and personnel (performance bias) All‐cause mortality | Low risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants' allocation; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Hypoglycaemic episodes | High risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants’ allocation; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Adverse events other than hypoglycaemic episodes | High risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants’ allocation; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Cardiovascular events | Low risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants’ allocation; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Renal failure | Low risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants’ allocation; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Infection events | High risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants’ allocation; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Mean blood glucose during intervention | High risk | Comment: open to personnel. The groups of interest were managed according a protocol with substantial differences that could reveal the participants’ allocation; outcome measure likely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Infection events | Unclear risk | Comment: open trial |
| Blinding of outcome assessment (detection bias) All‐cause mortality | Low risk | Comment: open trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Hypoglycaemic episodes | Unclear risk | Comment: open trial |
| Blinding of outcome assessment (detection bias) Adverse events other than hypoglycaemic episodes | Unclear risk | Comment: open trial |
| Blinding of outcome assessment (detection bias) Cardiovascular events | Low risk | Comment: open trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Renal failure | Low risk | Comment: open trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Mean blood glucose during intervention | Unclear risk | Comment: open trial |
| Incomplete outcome data (attrition bias) All‐cause mortality | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Hypoglycaemic episodes | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Adverse events other than hypoglycaemic episodes | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Cardiovascular events | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Renal failure | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Infection events | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Mean blood glucose during intervention | Low risk | Comment: probably no attrition |
| Selective reporting (reporting bias) | Unclear risk | Comment: trial protocol or register record unavailable. The outcomes of interest were described ambiguously |
| Other bias | Low risk | Nothing detected |