Study ID | |
Duncan 2018 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00524472 Primary outcome measure(s): any major morbidity/30‐day mortality (time frame: within 30 days post surgery) a composite (any versus none) of the following major postoperative complications occurring: 1. All‐cause postoperative mortality. 2. Failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intra aortic balloon counter pulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation. 3. Serious postoperative infection. 4. Acute postoperative kidney injury requiring renal replacement therapy. 5. New postoperative focal or global neurologic deficit. Secondary outcome measure(s): 1. Post operative atrial fibrillation (time frame: 15 ‐ 30 days post operative). Evidence suggests that maintaining intra‐operative normoglycaemia during cardiac surgery while providing exogenous glucose and high‐dose insulin may decrease post‐operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinaemic‐normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery 2. Duration of hospitalisation (time frame: starting post operative day one to discharge from hospital, on an average of 8 days), days from date of surgery to hospital discharge 3. Duration of intensive care stay (time frame: ICU stay hours during hospital stay after surgery, on average of 25 hours), hours from date of surgery to discharge from intensive care unit 4. All‐cause mortality (time frame: one year post operative): all‐cause mortality identified during one‐year follow‐up 5. Composite of minor postoperative complications (time frame: within 30 days after surgery): composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalisation, and all‐cause hospital readmission within 30 days Other outcome measure(s): — Trial results available in trial register: yes (last verified: January 19,2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): all‐cause postoperative mortality; failure to wean from cardiopulmonary bypass or postoperative low cardiac index (less than 1.8 l · min–1 · m–2) requiring mechanical circulatory support with intra‐aortic balloon counter‐pulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation; serious postoperative infection including any of the following infectious complications: mediastinitis, sternal wound infection requiring surgical debridement, sepsis, or pneumonia requiring mechanical ventilatory support; acute postoperative kidney injury requiring renal replacement therapy; and (5) new postoperative focal (aphasia, decrease in limb function, hemiparesis) or global (diffuse encephalopathy with greater than 24h of severely altered mental status or failure to awaken postoperatively) neurologic deficit. Secondary outcome measure(s): postoperative atrial fibrillation, defined as the occurrence of new‐onset postoperative atrial fibrillation after cardiac surgery, duration of hospitalisation (days) and intensive care unit stay (days), and 1‐year all‐cause mortality Other outcome measure(s): mechanical ventilation greater than 72h, low cardiac index (cardiac index less than 1.8 l · min–1 · m–2 despite adequate fluid replacement (lack of haemodynamic response to repeated fluid administration of crystalloid or colloid intravascular solutions) and high‐dose inotropic support for greater than 4h), acute kidney injury (increase in creatinine greater than 100%), hospitalisation greater than 30 days, and all‐cause hospital readmission within 30 days | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): composite of 30‐day mortality, mechanical circulatory support, infection, renal or neurologic morbidity Secondary outcome measure(s): — Other outcome measure(s): — | |
Wallia 2017 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT01211730 Primary outcome measure(s): rejection of liver transplant (within 1 year of transplantation) Secondary outcome measure(s): hypoglycaemia (within first 3 days following transplantation), infection rates (within 1 year following transplantation), re‐hospitalisation rates (within 1 year following transplantation), overall graft survival at 1 year (1 year following transplantation), death within 1 year (between 1 day and 1 year) Other outcome measure(s): — Trial results available in trial register: yes (last verified: January 19,2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary outcome was the number of patients experiencing an episode of rejection within 1 year after transplantation Secondary outcome measure(s): the principal secondary outcomes was the number of patients experiencing an infection within 1 year after transplantation. Additional secondary outcomes were divided into inpatient outcomes (episodes of hypoglycaemia, including symptoms occurring when hypoglycaemic, ICU length of stay, hospital length of stay, and death) and outpatient outcomes (re‐hospitalisation, raft survival, and death) Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — | |
Wahby 2016 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): operative mortality, renal dysfunction, acute renal failure required postoperative dialysis, postoperative permanent neurological deficit, sternal wound infection, leg infection and need for postoperative inotropic, all patients were followed up regarding duration of mechanical ventilation postoperatively, the occurrence of postoperative atrial fibrillation (AF), and perioperative myocardial infarction | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): operative mortality and postoperative outcome | |
Parekh 2016 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT01643382 Primary outcome measure(s): incidence of poor graft function after kidney transplant (time frame: 7 days after transplant). Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of < 10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine > 3 mg/dL 5 days after transplant without dialysis) Secondary outcome measure(s): Secondary endpoints will include wound infection, length of hospital stay, 30 day mortality, hypoglycaemic episodes (glucose <70 mg/dL) and stroke Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19,2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): poor graft function defined by the need for dialysis within seven days of transplant or a failure of the serum creatinine to drop by more than 10% for three consecutive days.The primary safety measure was the number of severe hypoglycaemic events (blood glucose <40 mg/dL) Secondary outcome measure(s): DGF (need for dialysis within seven days of transplant), perioperative death, stroke, and seizure, as well as serum creatinine and estimated GFR, using the modification of diet in renal disease study calculation, at 30 days, six months, and one year Other outcome measure(s): graft‐specific outcomes were biopsy‐proven rejection and graft loss | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): poor graft function (dialysis within seven days of transplant or failure of serum creatinine to fall by 10% for three consecutive days) Secondary outcome measure(s): — Other outcome measure(s): — | |
Yuan 2015 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): blood glucose concentrations, insulin administration, volume of enteral and parenteral nutrition, and additional intravenous glucose administered were recorded. Serious adverse events included severe hypoglycaemia and severe hyperglycaemia. Outcome measures included postoperative morbidity and mortality rates Secondary outcome measure(s): — Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): blood glucose concentrations, insulin administration, and postoperative morbidity and mortality Secondary outcome measure(s): — Other outcome measure(s): — | |
Umpierrez 2015 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT01361594 Primary outcome measure(s): number of subjects that were diagnosed for perioperative complications (time frame: within 6 months of hospitalisation. Number of participants that presented at least 1 complication including sternal wound infection, bacteraemia, acute renal failure, respiratory failure, and major cardiovascular events during the current hospitalisation and up to 6 months after hospitalisation Hospital Mortality (time frame: average 1 month during the hospitalisation). Mortality is defined as death occurring during admission, either during ICU or after transition to non‐ICU admission Secondary outcome measure(s): 1. glycaemic control (time frame: average 1 month during the hospitalisation): a. hyperglycaemic events (BG > 200 mg/dL) in ICU and non‐ICU, b. hypoglycaemic events (BG < 70 mg/dL; severe hypoglycaemia (BG < 40 mg/dL) 2. major cardiovascular events (time frame: average 1 month during the hospitalisation): a. acute myocardial infarction: (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: ischaemic symptoms, development of pathologic Q waves on the electrocardiogram, electrocardiographic changes indicative of ischaemia (ST‐segment elevation or depression), or coronary artery intervention (e.g., coronary angioplasty) b. congestive heart failure c. cardiac arrhythmias: malignant arrhythmia 3. acute renal failure (time frame: average 1 month during the hospitalisation): new‐onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline 4. respiratory failure, defined as PaO2 Value < 60 mm Hg while breathing Air or a PaCO2 > 50 mm Hg. (time frame: average 1 month during the hospitalisation) Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg. 5. ICU and hospital length of stay, and ICU readmissions (time frame: average 1 month during the hospitalisation) ICU and hospital length of stay, and ICU readmissions 6. surgical wound infection (time frame: average 1 month during the hospitalisation) superficial and deep sternal wound infection 7. pneumonia (CDC Criteria) (time frame: average 1 month during the hospitalisation) pneumonia (CDC criteria) 8. cerebrovascular events (time frame: average 1 month during the hospitalisation) permanent stroke and reversible ischaemic neurologic deficit 9. duration of ventilatory support and ICU readmission (time frame: average 1 month during the hospitalisation) duration of ventilatory support and ICU readmission 10. thirty day mortality (time frame: within 30 days of discharge) thirty day mortality 11. number of hospital readmissions and emergency room visits (time frame: within 30 days after discharge) number of hospital readmissions and emergency room visits 12. incidence of organ failures assessed by the daily SOFA score (time frame: average 1 month during the hospitalisation) incidence of organ failures assessed by the daily SOFA score 13. measures of inflammation (time frame: average 1 month during the hospitalisation) measures of inflammation (C‐reactive protein, TNF‐alpha; IL‐6) and oxidative stress markers 14. major cardiovascular events (time frame: within 3 months after discharge) a. acute myocardial infarction: (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischaemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischaemia (ST‐segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty). b. congestive heart failure ‐c. cardiac arrhythmias: malignant arrhythmia 15. surgical wound infection (time frame: within 3 months after discharge) superficial and deep sternal wound infection 16. pneumonia (CDC Criteria) (time frame: within 3 months after discharge) pneumonia (CDC criteria) 17. cerebrovascular events (time frame: within 3 months after discharge) permanent stroke and reversible ischaemic neurologic deficit Other outcome measure(s): — Trial results available in trial register: yes (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): primary outcome was differences in a composite of complications, including mortality, wound infection, pneumonia, bacteraemia, respiratory failure, acute kidney injury, and major cardiovascular events Secondary outcome measure(s): the secondary outcome was to compare differences between intensive and conservative glucose control on the following: 1. glycaemic control, including mean daily and fasting glucose concentration, number of hypoglycaemic events (<70 mg/dL) and severe hypoglycaemia (<40 mg/dL), and glycaemic variability 2. individual complications: MACE as defined per the American College of Cardiology–American Heart Association, including acute myocardial infarction, congestive heart failure, and cardiac arrhythmias; acute kidney injury, defined as an increment in creatinine level <50% from baseline; respiratory failure, defined as the need for ventilator assistance for longer than 48 h; pneumonia; cerebrovascular events; surgical wound infections recorded as deep sternal wound infection, defined as chest wound infection involving the sternum or mediastinal tissues and as superficial sternal wound infection as those chest wound infections involving the skin or subcutaneous tissues; mortality was recorded during admission, either during ICU, transition to non‐ICU hospital setting, or 90 days after discharge Other outcome measure(s): we collected information on hospital length of stay, ICU readmissions, reoperations, and number of hospital readmissions and emergency room visits after discharge | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): primary outcome was differences in a composite of complications, including mortality, wound infection, pneumonia, bacteraemia, respiratory failure, acute kidney injury, and major cardiovascular events Secondary outcome measure(s): — Other outcome measure(s): — | |
Hermayer 2012 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00609986 Primary outcome measure(s): delayed graft function (time frame: 10 days), acute/active rejection (time frame 30 months) Secondary outcome measure(s): severe hypoglycaemia (time frame: 30 months) blood glucose less than 40 mg/dL, severe hyperglycaemia (time frame: 30 month) blood glucose greater than 350 mg/dL Other outcome measure(s): — Trial results available in trial register: yes (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the surrogate endpoint of DGF was chosen as the primary outcome variable for this study Secondary outcome measure(s): glycaemic control, graft loss and graft survival Other outcome measure(s):— | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): DGF Secondary outcome measure(s): glycaemic control, graft survival, and acute rejection episodes Other outcome measure(s): — | |
Abdelmalak 2013 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00995501 Primary outcome measure(s): major perioperative morbidity: primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of 15 major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30‐day mortality Secondary outcome measure(s): 1 year mortality, all‐cause mortality Other outcome measure(s): — Trial results available in trial register: yes (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary outcome was a collapsed composite endpoint (any vs none) defined as the occurrence of at least one of the 15 major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30‐day mortality Secondary outcome measure(s): 1 year mortality Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): the primary outcome was a collapsed composite of 15 major complications and 30 days mortality Secondary outcome measure(s): — Other outcome measure(s): — | |
Desai 2012 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary end points were 2‐fold: superiority hypothesised for glucose control and target management and non‐inferiority hypothesised for complications and outcomes. Superiority end points included time to target glucose range, amount of insulin given, number of readings in target range, and number of patients with hypoglycaemic events (BG < 60 mg/dL and BG < 40 mg/dL). Non‐inferiority end points included perioperative renal failure, deep sternal wound infection, pneumonia, length of stay, atrial fibrillation, and operative mortality (death within 30 days) Secondary outcome measure(s): — Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): patient perioperative outcomes | |
Lazar 2011 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00460499 Primary outcome measure(s): glycaemic control, postoperative morbidity, inflammatory markers Secondary outcome measure(s): free fatty acid levels Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): incidence of major adverse events (MAEs), changes in serum glucose, and the incidence of hypoglycaemic episodes Secondary outcome measure(s): time on the ventilator defined as the time of admission to the ICU to the time of extubation, length of ICU, and hospital stay, all of which was standardised using, weight gain defined as the difference between the weight the evening before surgery to 5 am the day after surgery,an inotropic score that ranged from 0 to 4 (0 = no inotropic support; 1 = dopamine at 2 μg/kg for <24 hours; 2 = dopamine > 2 μg/kg for >24 hours; 3 = 2 inotropic agents; 4 = inotropic agents and intra‐aortic balloon support), the amount of insulin administered, and the cardiac index during the study Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): incidence of major adverse events ( 30‐day mortality, myocardial infarction, neurologic events, deep sternal infections, and AF), the level of serum glucose, and the incidence of hypoglycaemic events Secondary outcome measure(s): — Other outcome measure(s): — | |
Cao 2010 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary outcome was postoperative short‐term complication rate Secondary outcome measure(s): the secondary outcomes included postoperative 28‐day mortality rate, HOMA‐IR score, and HLA‐DR Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — | |
Glucontrol 2009 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00107601 Primary outcome measure(s): mortality in the intensive care unit (ICU) Secondary outcome measure(s): hospital mortality, 28 day mortality, length of ICU stay, length of hospital stay, number of episodes of hypoglycemia and associated clinical signs, infectious morbidity, incidence of organ failures, number of red‐cell transfusions, number of days spent in ICU without life‐support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy, daily SOFA (sequential organ failure assessment) score Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary outcome variable was the all‐cause absolute mortality during the ICU stay Secondary outcome measure(s): secondary outcome variables included hospital and 28‐day mortality, ICU and hospital, Length of stay (LOS), incidence of organ failures assessed by the daily SOFA score, rate of hypoglycaemia and the SOFA score on the day of hypoglycaemia, duration of mechanical ventilation, inotrope/ vasopressor and renal replacement therapy, number of packed red blood cells transfusion, febrile days and days with therapeutic anti‐infective agents Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — | |
NICE SUGAR 2009 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00220987 Primary outcome measure(s): all‐cause mortality at 90 days Secondary outcome measure(s): all cause mortality at 28 days, length of intensive care unit stay, length of hospital stay, the need for organ support (inotropes, renal replacement therapy and positive pressure ventilation), incidence of blood stream infections, incidence and severity of hypoglycaemia, extended Glasgow outcome score Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): death from any cause within 90 days after randomization, in an analysis that was not adjusted for baseline characteristics Secondary outcome measure(s): survival time during the first 90 days, cause‐specific death, and durations of mechanical ventilation, renal‐replacement therapy, and stays in the ICU and hospital Other outcome measure(s): death from any cause within 28 days after randomization, place of death (ICU, hospital ward, or other), incidence of new organ failure, positive blood culture, receipt of red‐cell transfusion, and volume of the transfusion | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): death from any cause within 90 days after randomization Secondary outcome measure(s): — Other outcome measure(s): — | |
Subramaniam 2009 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary endpoint was defined as a composite rate of the following intra pocedural and post porcedural major cardiovascular events at hospital discharge: all‐cause death, myocardial infarction, acute congestive heart failure Secondary outcome measure(s): secondary endpoints included the following efficacy and safety endpoints: (!) blood glucose levets al 4‐h intervals starting from 4 h after the procedure and ending at 48h, (2) rate of hypoglycaemia defined as a glucose level less than 60mg/dL, (3) rate of glucose concentrations greater than 150 mg/dL, (4) graft failure or a need for reintervention (reoperation due to graft failure or lack of peripheral pulses in the postoperative period), (5) surgical site of infection, (6) acute renal insufficiency (a 25% change in creatinine from before surgery to after surgery), (7) hospital duration of stay (from the date of surgery to discharge from the hospital) Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): the primary endpoint was a composite of all‐cause death, myocardial infarction, and acute congestive heart failure Secondary outcome measure(s): the secondary endpoints were blood glucose concentrations, rates of hypoglycaemia (< 60 mg/dL) and hyperglycaemia (> 150 mg/dL), graft failure or reintervention, wound infection, acute renal insufficiency, and duration of stay Other outcome measure(s): — | |
Chan 2009 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00370643 Primary outcome measure(s): 1. Duration of intubation 2. ICU length 3. Blood transfusion 4. Infection rate 5. Renal dysfunction 6. Neurological dysfunction 7. Hospital length 8. Mortality Secondary outcome measure(s): 1. Length of surgery 2. Length of cardiopulmonary bypass 3. Physical status 4. EuroSCORE 5. Parsonnet 6. Canadian Multicenter index Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): 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 Secondary outcome measure(s): — Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycaemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital Secondary outcome measure(s): the secondary outcome was a combined end‐point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days) Other outcome measure(s): — | |
De La Rosa 2008 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: study ID NCT00966421 does not exist in ClinicalTrials.gov Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): 28‐day all‐cause mortality Secondary outcome measure(s): ICU mortality; hospital mortality; incidence of infections in the ICU (ventilator‐associated pneumonia, urinary infections, catheter‐related infections and primary bacteraemia); ICU length of stay; days of mechanical ventilation and incidence of severe hypoglycaemia Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): mortality at 28 days Secondary outcome measure(s): — Other outcome measure(s): — | |
Gandhi 2007 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00282698 Primary outcome measure(s): mortality, sternal wound infections, stroke, cardiac arrhythmias, renal failure Secondary outcome measure(s): length of ICU stay, length of hospital stay, safety of study insulin infusion, efficacy of study insulin infusion Other outcome measure(s): — Trial results available in trial register: no (last verified: January 19, 2021) | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): death, sternal wound infections, prolonged pulmonary ventilation, cardiac arrhythmias (new‐onset atrial fibrillation, heart block requiring permanent pacemaker, or cardiac arrest), stroke, and acute renal failure within 30 days after surgery Secondary outcome measure(s): secondary outcome measures were length of stay in the ICU and hospital Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): the primary outcome was a composite of death, sternal infections, prolonged ventilation, cardiac arrhythmias, stroke, and renal failure within 30 days after surgery Secondary outcome measure(s): the primary outcome was a composite of death, sternal infections, prolonged ventilation, cardiac arrhythmias, stroke, and renal failure within 30 days after surgery Other outcome measure(s): — | |
Li 2006 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — Trial results available in trial register: — | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): the primary endpoints were incidences of operative mortality and sternal wound infection Secondary outcome measure(s): the secondary endpoint was the adequacy of blood‐glucose control Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): Secondary outcome measure(s): Other outcome measure(s): the adequacy of postoperative blood glucose control and clinical outcome were evaluated | |
Lazar 2004 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — Trial results available in trial register: — | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): to determine whether tight perioperative glycaemic control in patients with diabetes undergoing CABG with a modified GIK solution would optimise myocardial metabolism and improve perioperative outcomes Secondary outcome measure(s): to determine whether the early beneficial effects of tight glycaemic control would result in improved survival, a decreased incidence of ischaemic events, and reduced wound complications Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): to determine whether tight glycaemic control with a modified glucose‐insulin‐potassium solution in patients with diabetes undergoing CABG would improve perioperative outcomes Secondary outcome measure(s): — Other outcome measure(s): — | |
Rassias 1999 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — Trial results available in trial register: — | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): to examine the effect of aggressive insulin therapy on Polymorphonuclear neutrophils (PMNs) function in people with diabetes undergoing cardiac surgery Secondary outcome measure(s): — Other outcome measure(s): — | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): we tested the effect of an insulin infusion on perioperative neutrophil function in people with diabetes scheduled for coronary artery bypass surgery Secondary outcome measure(s): — Other outcome measure(s): — | |
—: denotes not reported
aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trial registers). bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents or multiple reports of a primary trial). cPrimary and secondary outcomes refer to verbatim specifications in publication/records. Unspecified outcome measures refer to all outcomes not described as primary or secondary outcome measures. EMA: European Medicines Agency; FDA: Food and Drug Administration (US); mo: month(s); NA: not applicable; NT: no trial document available; ICU: intensive care unit ; DGF: delayed graft function; AF: atrial fibrillation; GFR: glomerular filtration rate ; BG: blood glucose, PaO2: partial pressure of oxygen; SOFA: sequential organ failure assessment; CDC: Centers for Disease Control and Prevention; MACE: mayor adverse cardiac events; CABG: coronary artery bypass graft. |