Crit Care Resusc
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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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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.
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Most studies of the rapid response team (RRT) investigate the effect of introducing an RRT on outcomes of all hospitalised patients. Less information exists on RRT patient epidemiology, or changes in RRT call numbers with time. ⋯ Annual RRT calls are increasing in many Australian hospitals, and now affect more than 14 700 patients annually. Inhospital mortality of RRT patients is about 25%, and about 20% of patients who die in hospital are reviewed by the RRT. Further research is needed to understand the reason for the high inhospital mortality of RRT patients.
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Multicenter Study Observational Study
Oxygen therapy in non-intubated adult intensive care patients: a point prevalence study.
Oxygen is commonly administered to intensive care unit patients. Although there is knowledge of how oxygen is administered to mechanically ventilated patients, there are few data about its use in non-intubated ICU patients. ⋯ Oxygen therapy is commonly administered to non-intubated adult patients in New Zealand and Australian ICUs. Most patients received oxygen by simple nasal cannulae, and oxygen therapy prescriptions were often absent or incomplete. We advise continuing education to ensure that oxygen is prescribed, administered and documented correctly.
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Randomized Controlled Trial
Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.
The Protocolized Care for Early Septic Shock study is a randomised, multicentre, prospective, three-arm, parallel-group trial of alternative resuscitation strategies for early septic shock. ⋯ By using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.