Crit Care Resusc
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Randomized Controlled Trial Multicenter Study Comparative Study
Statistical analysis plan for the Crystalloid Versus Hydroxyethyl Starch Trial (CHEST).
The Crystalloid Versus Hydroxyethyl Starch Trial (CHEST) is a 7000-patient, multicentre, randomised controlled trial comparing the effects of 6% hydroxyethyl starch (130/0.4) to normal saline for fluid resuscitation in intensive care patients. The trial design is based on the Saline Versus Albumin Fluid Evaluation (SAFE) study and will be the largest fluid resuscitation trial conducted to date. ⋯ We have developed a predetermined SAP for CHEST. This plan accords with high-quality standards of internal validity to minimise analysis bias.
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Intensive care patients with traumatic brain injury (TBI) are at high risk of developing deep vein thrombosis (DVT). A high rate of DVT was reported before routine thromboprophylaxis, but the current DVT rate in TBI patients receiving best-practice mechanical and pharmacological prophylaxis is unknown. ⋯ Mechanical and pharmacological prophylaxis appeared to be effective. The incidence of clinically identified PE is of concern and suggests that thromboembolic sources other than large leg veins may not be being adequately controlled by modern thromboprophylaxis regimens.
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Recommended daily intake of sodium is 1- 2mmol/kg. Sodium administration is rarely separated from fluid administration in critically ill patients. ⋯ Sodium administration to this cohort of critically ill patients requiring prolonged mechanical ventilation was high. Further studies should examine ways of limiting the amount of sodium administered to such patients and to examine if this influences patient outcomes.
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To compare registrar sleep and supervision hours before and after a change in roster to accommodate more senior registrar (SR) positions, and to identify risky patterns of sleep on night shifts. ⋯ Changing the registrar roster to meet the training demands of our senior trainees did not adversely affect registrar sleep or supervision. Registrars may be taking on unnecessary risk due to poor sleep hygiene around night shifts. We suggest sleep education and scheduled sleep time during night shifts.