Crit Care Resusc
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Multicenter Study
Sodium administration in critically ill patients in Australia and New Zealand: a multicentre point prevalence study.
Inadvertent sodium administration in excess of recommended daily requirements has been reported during routine care of critically ill patients. ⋯ This point prevalence study suggests that sodium administration in excess of recommended daily requirements may be common in Australia and New Zealand ICUs. The main sodium source was IV maintenance fluids, followed by fluid boluses and drug boluses.
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Randomized Controlled Trial
The Protocolised Management in Sepsis (ProMISe) trial statistical analysis plan.
The Protocolised Management in Sepsis (ProMISe) trial is an open, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, goal directed, protocolised resuscitation compared with usual resuscitation for patients presenting to emergency departments (EDs) in the United Kingdom with early signs of severe sepsis or septic shock. The rationale for the ProMISe trial derives from a single-centre United States RCT that reported a reduction in hospital mortality from 46.5% to 30.5%. ⋯ In keeping with best practice, we have developed a statistical analysis plan for the ProMISe trial and place it in the public domain before inspecting data from the trial.
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Despite extensive work to improve early recognition of and response to abnormal vital signs, a failure or delay in response to clinical deterioration by activating a medical emergency team (MET) can affect patient safety. ⋯ Despite one in seven patients fulfilling MET criteria, MET activation occurred infrequently. The presence of MET criteria was associated with a doubling of the hospital LOS. Escalation of care in response to detection of MET criteria fulfillment was variable. Further research tracking patient management is needed to understand the decision-making process that occurs in the presence of clinical deterioration.
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Randomized Controlled Trial
Statistical analysis plan for the HEAT trial: a multicentre randomised placebo-controlled trial of intravenous paracetamol in intensive care unit patients with fever and infection.
We describe the statistical analysis plan (SAP) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (HEAT) trial, a 700-patient, prospective, randomised, Phase 2b, multicentre, double-blind, parallel-groups, placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection. ⋯ We developed an SAP for the HEAT trial, and produced a mock Consolidated Standards of Reporting Trials diagram and tables. Our prespecified SAP accords with high-quality standards of internal validity and should minimise future analysis bias.