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      Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled Trial 

      , MD, FRCP (UK), MRCP (UK), MBChB 1 , , , PhD, BSc (Hons) 2 , , MD, FRCA 1
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      intensive care, insulin, glycaemic control

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          Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of “tight” glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00’s, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies.


          The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting.


          This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction.


          The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018.


          This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome.

          Trial Registration

          International Standard Randomized Controlled Trial Number ISRCTN00550641; http://www.isrctn.com/ISRCTN00550641 (Archived at WebCite: http://www.webcitation.org/6xk8NXxNv).

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          Most cited references27

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          Stress hyperglycemia and prognosis of stroke in nondiabetic and diabetic patients: a systematic overview.

          "Stress" hyperglycemia may be associated with increased mortality and poor recovery in diabetic and nondiabetic patients after stroke. A systematic review and meta-analysis of the literature relating acute poststroke glucose levels to the subsequent course were done to summarize and quantify this relationship. A comprehensive literature search was done for cohort studies reporting mortality and/or functional recovery after stroke in relation to admission glucose level. Relative risks in hyperglycemic compared with normoglycemic patients with and without diabetes were calculated and meta-analyzed when possible. Thirty-two studies were identified; relative risks for prespecified outcomes were reported or could be calculated in 26 studies. After stroke of either subtype (ischemic or hemorrhagic), the unadjusted relative risk of in-hospital or 30-day mortality associated with admission glucose level >6 to 8 mmol/L (108 to 144 mg/dL) was 3.07 (95% CI, 2.50 to 3.79) in nondiabetic patients and 1.30 (95% CI, 0.49 to 3.43) in diabetic patients. After ischemic stroke, admission glucose level >6.1 to 7.0 mmol/L (110 to 126 mg/dL) was associated with increased risk of in-hospital or 30-day mortality in nondiabetic patients only (relative risk=3.28; 95% CI, 2.32 to 4.64). After hemorrhagic stroke, admission hyperglycemia was not associated with higher mortality in either diabetic or nondiabetic patients. Nondiabetic stroke survivors whose admission glucose level was >6.7 to 8 mmol/L (121 to 144 mg/dL) also had a greater risk of poor functional recovery (relative risk=1.41; 95% CI, 1.16 to 1.73). Acute hyperglycemia predicts increased risk of in-hospital mortality after ischemic stroke in nondiabetic patients and increased risk of poor functional recovery in nondiabetic stroke survivors.
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            Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial).

            The primary objective of this 6-week, parallel-group, open-label, randomized, multicenter trial was to compare rosuvastatin with atorvastatin, pravastatin, and simvastatin across dose ranges for reduction of low-density lipoprotein (LDL) cholesterol. Secondary objectives included comparing rosuvastatin with comparators for other lipid modifications and achievement of National Cholesterol Education Program Adult Treatment Panel III and Joint European Task Force LDL cholesterol goals. After a dietary lead-in period, 2,431 adults with hypercholesterolemia (LDL cholesterol > or =160 and <250 mg/dl; triglycerides <400 mg/dl) were randomized to treatment with rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg. At 6 weeks, across-dose analyses showed that rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2% more than atorvastatin 10 to 80 mg, 26% more than pravastatin 10 to 40 mg, and 12% to 18% more than simvastatin 10 to 80 mg (all p <0.001). Mean percent changes in high-density lipoprotein cholesterol in the rosuvastatin groups were +7.7% to +9.6% compared with +2.1% to +6.8% in all other groups. Across dose ranges, rosuvastatin reduced total cholesterol significantly more (p <0.001) than all comparators and triglycerides significantly more (p <0.001) than simvastatin and pravastatin. Adult Treatment Panel III LDL cholesterol goals were achieved by 82% to 89% of patients treated with rosuvastatin 10 to 40 mg compared with 69% to 85% of patients treated with atorvastatin 10 to 80 mg; the European LDL cholesterol goal of <3.0 mmol/L was achieved by 79% to 92% in rosuvastatin groups compared with 52% to 81% in atorvastatin groups. Drug tolerability was similar across treatments.
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              Glucose control lowers the risk of wound infection in diabetics after open heart operations.

              Elevated blood glucose levels in the postoperative period are associated with an increased risk of deep wound infection in diabetic individuals undergoing open heart operations at Providence St. Vincent Hospital. Of 8,910 patients who underwent cardiac operations between 1987 and 1993, 1,585 (18%) were diabetic. The rate of deep sternal wound infections in diabetic patients was 1.7%, versus 0.4% for nondiabetics. Nine hundred ninety patients had their operation before implementation of the protocol and 595 after implementation. Charts of all diabetic patients were reviewed. Mean blood glucose levels were calculated from documented results of finger-stick glucometer testing. Thirty-three diabetic patients suffered 35 deep wound infections: 27 sternal (1.7%) and eight at the donor site (0.5%). Infected diabetic patients had a higher mean blood glucose level through the first 2 postoperative days than noninfected patients (208 +/- 7.1 versus 190 +/- 0.8 mg/dL; p < 0.003) and had a greater body mass index (31.5 +/- 1.4 versus 28.6 +/- 0.1 kg/m2; p < 0.05). Multivariable logistic regression showed that mean blood glucose level for the first 2 days (p = 0.002), obesity (p < 0.002), and use of the internal mammary artery (p < 0.02) were all independent predictors of deep wound infection. Institution of a protocol of postoperative continuous intravenous insulin to maintain blood glucose level less than 200 mg/dL was begun in September 1991. This protocol resulted in a decrease in blood glucose levels for the first 2 postoperative days and a concomitant decrease in the proportion of patients with deep wound infections, from 2.4% (24/990) to 1.5% (9/595) (p < 0.02). The incidence of deep wound infection in diabetic patients was reduced after implementation of a protocol to maintain mean blood glucose level less than 200 mg/dL in the immediate postoperative period.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                March 2018
                08 March 2018
                : 7
                : 3
                : e44
                [1] 1 Critical Care Trials Group University of Oxford Oxford United Kingdom
                [2] 2 Oxford Clinical Trials Research Unit University of Oxford Oxford United Kingdom
                Author notes
                Corresponding Author: Peter J Watkinson peter.watkinson@ 123456ndcn.ox.ac.uk
                Author information
                ©Peter J Watkinson, Vicki S Barber, J Duncan Young. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 28 April 2016
                : 16 June 2016
                : 28 October 2016
                : 2 June 2017

                intensive care,insulin,glycaemic control
                intensive care, insulin, glycaemic control


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