Journal of critical care
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Journal of critical care · Jun 2007
Randomized Controlled TrialLowering of glucose in critical care: a randomized pilot trial.
Similar to cardiac surgery patients, medical-surgical critically ill patients may benefit from intensive insulin therapy. The objectives of this pilot trial were to evaluate the feasibility of a randomized trial of intensive insulin therapy with respect to (a) achieving target glucose values in the 2 ranges of 5 to 7 and 8 to 10 mmol/L and (b) uncovering problems with the protocol in anticipation of a larger trial. ⋯ In this pilot trial of ICU patients with high illness severity, glucose values were in the 2 target ranges only 40% of the time, using well-accepted initiation and maintenance insulin infusion algorithms. A large randomized trial of glycemic control is feasible in this population to examine clinically important outcomes, but will require refined insulin algorithms and more comprehensive behavior change strategies to achieve target values.
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Journal of critical care · Mar 2006
Randomized Controlled Trial Multicenter StudyClinical trial design--effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome.
This paper describes the methodology of a clinical trial of prone positioning in pediatric patients with acute lung injury (ALI). Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/acute respiratory distress syndrome without the risk of serious iatrogenic injury. It is not known if these improvements in oxygenation result in improvements in clinical outcomes. A clinical trial was needed to answer this question. ⋯ This paper describes the process, multidisciplinary input, and procedures used to support the design of the clinical trial, as well as the challenges faced by the clinical scientists during the conduct of the clinical trial.
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Journal of critical care · Dec 2005
Randomized Controlled Trial Multicenter Study Comparative StudyProphylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study.
There is no randomized trial comparing low-molecular weight heparin (LMWH) and unfractionated heparin (UFH) for thromboprophylaxis in medical-surgical ICU patients. The primary objective of this randomized pilot study on LMWH vs UFH was to assess the feasibility of conducting a large randomized trial with respect to timely enrollment and blinded study drug administration, practicality of twice-weekly lower limb ultrasounds to screen for deep venous thrombosis, LMWH bioaccumulation and dose adjustment in renal insufficiency, and recruitment rates for a future trial in medical-surgical intensive care unit (ICU) patients. Its additional goals were to evaluate the suitability of the exclusion criteria and to document the range of research activities that precede accrual of patients into a trial to plan multisite management. ⋯ This pilot study suggests that a multicenter randomized clinical trial comparing LMWH with UFH in critically ill medical-surgical patients is feasible. Pilot studies can improve the design of larger trials and may enhance successful timely completion.
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Journal of critical care · Sep 2004
Randomized Controlled Trial Clinical TrialThe effect of a managerial-based intervention on the occurrence of out-of-range-measurements and mortality in intensive care units.
To evaluate the effect of an organization-based managerial intervention on performance of intensive care units (ICUs). ⋯ The intervention reduced both the ICU and hospital mortalities and the incidences of the out-of-range measurements. Registering ORMs provides a feasible method for evaluating ICU performance and could help to optimize individual patient care.
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Journal of critical care · Jun 2004
Randomized Controlled Trial Comparative Study Clinical TrialComparison of nebulized epinephrine and terbutaline in patients with acute severe asthma: a controlled trial.
To compare the efficacy and tolerability of nebulized adrenaline and terbutaline in acute severe asthma. ⋯ Adrenaline nebulization was as effective and as well tolerated as terbutaline in acute severe asthma. No synergistic effect between terbutaline and adrenaline was observed.