Chan 2009.

Study characteristics
Methods	Study design: parallel randomised controlled clinical trial with randomisation ratio of 1:1
Participants	Inclusion criteria: adults from both genders who were older than 21 years of age and who were undergoing open‐heart cardiac surgery with CPB Exclusion criteria: renal dysfunction, reoperation, use of inotropic support, neurological dysfunction, chronic pulmonary obstructive disease, emergency or urgency Diagnostic criteria: — Setting: Instituto do Coraçao (InCor), Hospital das Clínicas Age group: adults Gender distribution: females and males Country where trial was performed: Brazil Co‐medications: general anaesthesia: sufentanil, atracurium and isoflurane. Others: midazolam, methylprednisolone, second‐generation cephalosporin, lactated Ringer's solution. If needed: red blood cell blood transfusion, aminocaproic acid.
Interventions	Intervention(s): intensive protocol, with target glucose level between 80 mg/dL and 130 mg/dL Comparator(s): control group (less intensive), with target glucose level between 160 mg/dL and 200 mg/dL Duration of intervention: during surgery and for 36 hours after surgery in the intensive care unit Duration of follow‐up: 30 days after surgery Run‐in period: none Number of study centres: 1
Outcomes	Reported outcome(s) in full text of publication: primary outcomes were clinical outcomes, which included the duration of mechanical ventilation from the operation room until extubation in the intensive care unit (ICU), the length of stay in the ICU, occurrence of infection (diagnosis of pneumonia, urinary tract infection, sepsis, septic shock, wound infection, blood stream infection, catheter infection), occurrence of hypoglycaemia (glucose level < 50 mg/dL), renal dysfunction (characterised as an increase in the level of creatinine higher than 50% of the baseline value), neurological dysfunction (diagnosis by hospital neurologist who was blinded to the protocol), red blood cell transfusion during the first 30 days after surgery, the length of stay in the hospital and mortality by 30 days after surgery
Study registration	Trial identifier:NCT00370643 Trial terminated early: no
Publication details	Language of publication: English Funding: non‐commercial funding (E.J. Zerbini Foundation) Publication status: peer‐reviewed journal
Stated aim of study	Quote: "In light of this suggestion, we aimed to investigate whether different targets of intraoperative and postoperative glucose (80 ‐ 130 mg/dL, 4.4 ‐ 7.2 mEq/L or 160 ‐ 200 mg/dL, 8.8 ‐ 11.1 mEq/L) could affect postoperative clinical outcomes after cardiac surgery with cardiopulmonary bypass"
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)	Unclear risk	Quote: "The patients were randomized into two groups through a lottery system" Comment: no details
Allocation concealment (selection bias)	Unclear risk	Comment: the system used to generate the randomisation sequence is susceptible to manipulation; details to prevent it were not described
Blinding of participants and personnel (performance bias) All‐cause mortality	Low risk	Comment: the trial was registered as open‐label according the ClinicalTrials.gov record; outcome measure unlikely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Hypoglycaemic episodes	High risk	Comment: the trial was registered as open‐label according the ClinicalTrials.gov record; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Adverse events other than hypoglycaemic episodes	High risk	Comment: the trial was registered as open‐label according the ClinicalTrials.gov record; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Renal failure	Low risk	Comment: the trial was registered as open‐label according the ClinicalTrials.gov record; outcome measure unlikely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Length of ICU and hospital stay	High risk	Comment: the trial was registered as open‐label according the ClinicalTrials.gov record; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Infection events	High risk	Comment: the trial was registered as open‐label according the ClinicalTrials.gov record; outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Infection events	Low risk	Quote: “The physicians and nurse who obtained the clinical data were blinded to the randomisation of the group”
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Quote: “The physicians and nurse who obtained the clinical data were blinded to the randomisation of the group”
Blinding of outcome assessment (detection bias) Hypoglycaemic episodes	Low risk	Quote: “The physicians and nurse who obtained the clinical data were blinded to the randomisation of the group”
Blinding of outcome assessment (detection bias) Adverse events other than hypoglycaemic episodes	Low risk	Quote: “The physicians and nurse who obtained the clinical data were blinded to the randomisation of the group”
Blinding of outcome assessment (detection bias) Renal failure	Low risk	Quote: “The physicians and nurse who obtained the clinical data were blinded to the randomisation of the group”
Blinding of outcome assessment (detection bias) Length of ICU and hospital stay	Low risk	Quote: “The physicians and nurse who obtained the clinical data were blinded to the randomisation of the group”
Incomplete outcome data (attrition bias) All‐cause mortality	Low risk	Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 109 participants; no dropouts were described according to the report
Incomplete outcome data (attrition bias) Hypoglycaemic episodes	Low risk	Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 109 participants; no dropouts were described according to the report
Incomplete outcome data (attrition bias) Adverse events other than hypoglycaemic episodes	Low risk	Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 109 participants; no dropouts were described according to the report
Incomplete outcome data (attrition bias) Renal failure	Low risk	Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 109 participants; no dropouts were described according to the report
Incomplete outcome data (attrition bias) Length of ICU and hospital stay	Low risk	Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 109 participants; no dropouts were described according to the report
Incomplete outcome data (attrition bias) Infection events	Low risk	Comment: the researchers did not report a sample size calculation for this trial. The trial randomised 109 participants; no dropouts were described according to the report
Selective reporting (reporting bias)	Unclear risk	Comment: study was not powered for the primary outcomes. All primary outcomes mentioned in the study protocol (NCT00370643) are reported in the results. Secondary outcomes in the protocol are not the same as the one reported in the publication. In the publication it is described in the abstract but not in the methods, and not reported ‐ just stated that it is not different between the two groups.
Other bias	Low risk	Nothing detected