Crit Care Resusc
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Randomized Controlled Trial Multicenter Study
The NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation) Study: statistical analysis plan.
The Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE-SUGAR) Study is the largest study to date of glycaemic control in critically ill patients. ⋯ We have developed a pre-determined statistical analysis plan for the NICE-SUGAR Study. This plan will be followed to avoid analysis bias arising from prior knowledge of the study findings.
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To determine whether operators with less than 3 months' formal anaesthesiology training have higher rates of complications when performing endotracheal intubation (ETI) in the intensive care unit than operators with longer formal anaesthesiology training. ⋯ ETIs performed in the ICU where the initial operator has less than 3 months' formal training in anaesthesiology appear not to be associated with more complications. However, this may be attributable to less experienced operators having more assistance and supervision, and to patient selection.
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To determine whether the introduction of a weekly multidisciplinary team meeting (MDTM) to a general intensive care unit improved selected clinical indicators of patient outcome, and staff satisfaction with patient care. ⋯ The introduction of a weekly MDTM to a general ICU did not improve selected clinical indicators of patient outcome or staff satisfaction with patient care.
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Randomized Controlled Trial Multicenter Study
The RENAL (Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy) study: statistical analysis plan.
The Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study is the largest interventional trial ever conducted in patients with acute renal failure. ⋯ We have developed a pre-determined statistical analysis plan for the RENAL trial. This plan will be adhered to in order to avoid introducing any analysis bias associated with prior knowledge of study findings.
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Albumin has been used for volume resuscitation and supplementation in critically ill patients for over 50 years. While regarded as a "gold standard" colloid solution, albumin is associated with substantial cost, and questions have been raised about its safety and efficacy. A large-scale randomised controlled trial (the Saline vs. ⋯ Similarly, there is no substantive evidence to justify the use of hyperoncotic albumin solutions for resuscitation or supplementation in critically ill patients. Albumin is a safe and effective resuscitation solution in critically ill patients without traumatic brain injury. However, the acquisition costs of albumin and synthetic colloids are more than those of crystalloids, and, as yet, colloids have not been proven to confer substantive benefits over crystalloids such as saline.