Li 2006.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled clinical trial with randomisation ratio of 1:1 | |
| Participants |
Inclusion criteria: participants with diabetes mellitus undergoing CABG for the first time Exclusion criteria: none Diagnostic criteria: in most cases before admission for surgery. Newly diagnosed diabetes was confirmed by a fasting blood glucose level of ≥ 200 mg/dL associated with an elevated level of haemoglobin A1c Setting: Mackay Memorial Hospital Age group: adults Gender distribution: females and males Country where trial was performed: Republic of China/Taiwan Co‐morbidities: hypertension: I: 84%, C: 88%; congestive heart failure: I: 57%, C: 59%; renal insufficiency: I: 10%, C: 14%; stroke: I: 8%, C: 17%; peripheral vascular disease: I: 4%, C: 2%; chronic obstructive pulmonary disease: I: 6%, C: 9%; previous myocardial infarction: I: 51%, C: 62%; left main stenosis: I: 25%, C: 31% |
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| Interventions |
Intervention(s): continuous insulin infusion (CII) Comparator(s): glucometer‐guided insulin (GGI) Duration of intervention: 5 days postoperative Duration of follow‐up: — Run‐in period: none Number of study centres: 1 Treatment before trial: diabetic control: insulin: I: 5.9%, C: 11.9%, oral hypoglycaemic agents: I: 86.3%, C: 78.6%; diuretics: I: 17.6%, C: 28.6%; inotropic agents: I: 7.8%, C: 4.8% |
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| Outcomes | Reported outcome(s) in full text of publication: the primary endpoints were incidence of operative mortality and sternal wound infection of operative mortality and sternal wound infection; the secondary endpoint was the adequacy of blood glucose control | |
| Study registration |
Trial identifier: — Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: non‐commercial funding Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote: "Postulating that continuous insulin infusion would provide better control of postoperative blood glucose levels, we designed this prospective, randomized study to test that hypothesis" | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “[…] the patients were randomly assigned to 1 of 2 groups for diabetic control” Comment: no additional details provided on randomisation sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Quote: “[…] the patients were randomly assigned to 1 of 2 groups for diabetic control” Comment: no additional details provided on randomisation sequence concealment |
| Blinding of participants and personnel (performance bias) All‐cause mortality | Low risk | Comment: open trial. The researchers report that as consequence of the trial not being blinded, 7 participants were withdrawn due to clinicians' concerns about participants’ glucose levels; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Adverse events other than hypoglycaemic episodes | High risk | Comment: open trial. The researchers report that as consequence of the trial not being blinded, 7 participants were withdrawn due to clinicians' concerns about participants’ glucose levels; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Cardiovascular events | Low risk | Comment: open trial. The researchers report that as consequence of the trial not being blinded, 7 participants were withdrawn due to clinicians' concerns about participants’ glucose levels; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Length of ICU and hospital stay | High risk | Comment: open trial. The researchers report that as consequence of the trial not being blinded, 7 participants were withdrawn due to clinicians' concerns about participants’ glucose levels; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Infection events | High risk | Comment: open trial. The researchers report that as consequence of the trial not being blinded, 7 participants were withdrawn due to clinicians' concerns about participants’ glucose levels; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Mean blood glucose during intervention | High risk | Comment: open trial. The researchers report that as consequence of the trial not being blinded, 7 participants were withdrawn due to clinicians' concerns about participants’ glucose levels; outcome measure likely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Infection events | Unclear risk | Comment: the trial report did not provide any detail on blinded assessment |
| Blinding of outcome assessment (detection bias) All‐cause mortality | Low risk | Comment: the trial report did not provide any detail on blinded assessment; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Adverse events other than hypoglycaemic episodes | Unclear risk | Comment: the trial report did not provide any detail on blinded assessment |
| Blinding of outcome assessment (detection bias) Cardiovascular events | Low risk | Comment: the trial report did not provide any detail on blinded assessment; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Length of ICU and hospital stay | Unclear risk | Comment: the trial report did not provide any detail on blinded assessment |
| Blinding of outcome assessment (detection bias) Mean blood glucose during intervention | Unclear risk | Comment: the trial report did not provide any detail on blinded assessment |
| Incomplete outcome data (attrition bias) All‐cause mortality | Unclear risk | Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 100 participants, but the researchers described many protocol deviations (see blinding of participants and personnel) and cross‐overs between groups that were excluded from final analyses |
| Incomplete outcome data (attrition bias) Adverse events other than hypoglycaemic episodes | Unclear risk | Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 100 participants, but the researchers described many protocol deviations (see blinding of participants and personnel) and cross‐overs between groups that were excluded from final analyses |
| Incomplete outcome data (attrition bias) Cardiovascular events | Unclear risk | Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 100 participants, but the researchers described many protocol deviations (see blinding of participants and personnel) and cross‐overs between groups that were excluded from final analyses |
| Incomplete outcome data (attrition bias) Length of ICU and hospital stay | Unclear risk | Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 100 participants, but the researchers described many protocol deviations (see blinding of participants and personnel) and cross‐overs between groups that were excluded from final analyses |
| Incomplete outcome data (attrition bias) Infection events | Unclear risk | Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 100 participants, but the researchers described many protocol deviations (see blinding of participants and personnel) and cross‐overs between groups that were excluded from final analyses |
| Incomplete outcome data (attrition bias) Mean blood glucose during intervention | Unclear risk | Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 100 participants, but the researchers described many protocol deviations (see blinding of participants and personnel) and cross‐overs between groups that were excluded from final analyses |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available; the trial report presented results on all outcome measures that were pre‐specified in the methods section as relevant. No power calculation was made for the primary outcome |
| Other bias | Low risk | Nothing detected |