Umpierrez 2015.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: aged between 18 and 80 years undergoing primary or a combination of CABG and other cardiac operations such as valve repair or aortic surgery who experienced perioperative hyperglycaemia, defined as a blood glucose > 140 mg/dL
Exclusion criteria: people with impaired renal function (serum creatinine ≥ 3.0 mg/dL or glomerular filtration rate < 30 mL/min/1.73 m2), hepatic failure, or history of hyperglycaemic crises and those at imminent risk of death (brain death or cardiac standstill) or pregnancy, or individual or next of kin unable to provide consent Diagnostic criteria: — Setting: Emory University Hospital, Emory Midtown Hospital, and Grady Memorial Hospital in Atlanta Age group: adults, elderly people Gender distribution: females and males Country where trial was performed: USA |
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| Interventions |
Intervention(s): continuous insulin infusion (CII) adjusted to maintain a glucose target between 100 mg/dL and 140 mg/dL in the ICU Comparator(s): CII adjusted to maintain a glucose level between 141 mg/dL and 180 mg/dL in the ICU Duration of intervention: until discontinuation of CII (at ICU discharge) Duration of follow‐up: 90 days after hospital discharge Run‐in period: none Number of study centres: 3 Treatment before trial: — Intervention: no antidiabetic agents 7 (9%); oral agents only 32 (45%); insulin alone 15 (20%); insulin + oral agents 20 (26%) Comparator: no antidiabetic agents 5 (7%); oral agents only 34 (48%); insulin alone 14 (20%); insulin + oral agents 18 (25%) |
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| Outcomes | Reported outcome(s) in full text of publication: the primary outcome was to determine differences between intensive and conservative glucose control on a composite of hospital mortality and perioperative complications, including sternal wound infection (deep and superficial), bacteraemia, respiratory failure, pneumonia, acute kidney injury, and MACE (acute myocardial infarction, congestive heart failure and cardiac arrhythmias). The secondary outcome was to compare differences between intensive and conservative glucose control. | |
| Study registration |
Trial identifier:NCT01361594 Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: a clinical research grant from the American Diabetes Association (7‐03‐CR‐35) and a grant from the Clinical and Translational Science Award program, National Institutes of Health, National Center for Research Resources (UL1 RR025008) Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote: "The optimal level of glycaemic control needed to improve outcomes in cardiac surgery patients remains controversial" | |
| Notes | Information exclusively on diabetes participants was provided by trial authors | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “A research pharmacist following a computer‐generated block randomization table coordinated randomization and treatment assignment” |
| Allocation concealment (selection bias) | Low risk | Quote: “A research pharmacist following a computer‐generated block randomization table coordinated randomization and treatment assignment” Comment: likely the pharmacist participated in the trial independently |
| Blinding of participants and personnel (performance bias) All‐cause mortality | Low risk | Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Hypoglycaemic episodes | High risk | Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Adverse events other than hypoglycaemic episodes | High risk | Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Cardiovascular events | Low risk | Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Renal failure | Low risk | Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Length of ICU and hospital stay | High risk | Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Infection events | High risk | Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Mean blood glucose during intervention | High risk | Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Infection events | Unclear risk | Comment: described as an open‐label trial |
| Blinding of outcome assessment (detection bias) All‐cause mortality | Low risk | Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Hypoglycaemic episodes | Unclear risk | Comment: described as an open‐label trial |
| Blinding of outcome assessment (detection bias) Adverse events other than hypoglycaemic episodes | Unclear risk | Comment: described as an open‐label trial |
| Blinding of outcome assessment (detection bias) Cardiovascular events | Low risk | Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Renal failure | Low risk | Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Length of ICU and hospital stay | Unclear risk | Comment: described as an open‐label trial |
| Blinding of outcome assessment (detection bias) Mean blood glucose during intervention | Unclear risk | Comment: described as an open‐label trial |
| Incomplete outcome data (attrition bias) All‐cause mortality | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Hypoglycaemic episodes | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Adverse events other than hypoglycaemic episodes | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Cardiovascular events | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Renal failure | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Length of ICU and hospital stay | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Infection events | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Incomplete outcome data (attrition bias) Mean blood glucose during intervention | Low risk | Comment: sample size calculation for 296 participants, adjusted to an expected low attrition rate (< 10%). Although 305 participants were randomised, 3 participants withdrew prior to the intervention initiation, and data for 302 participants were finally analysed |
| Selective reporting (reporting bias) | Unclear risk | Comment: all the outcomes in the trial register record were disclosed in the trial report, but a composite outcome of major morbidity and 30‐day mortality was used as primary outcome |
| Other bias | Low risk | Nothing detected |