Crit Care Resusc
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Randomized Controlled Trial Comparative Study
A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan.
To determine if using freshest available rather than standard-issue red blood cells (RBCs) can reduce mortality in critically ill intensive care unit patients. Our study is the largest ongoing randomised controlled trial (RCT) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill. ⋯ The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice. The TRANSFUSE trial will have important clinical and policy implications, regardless of the outcome.
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Randomized Controlled Trial
The IRONMAN trial: a protocol for a multicentre randomised placebo-controlled trial of intravenous iron in intensive care unit patients with anaemia.
Allogeneic red blood cell (RBC) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit, and the blood supplies it requires are an increasingly scarce and costly resource. Despite high levels of compliance with recommended transfusion thresholds in the ICU, RBC transfusion remains common. Novel interventions to reduce the incidence of RBC transfusion are required. ⋯ The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion, compared with placebo in addition to standard care. The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible.
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Randomized Controlled Trial
The CALORIES trial: statistical analysis plan.
The CALORIES trial is a pragmatic, open, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral route compared with early nutritional support via the enteral route in unplanned admissions to adult general critical care units (CCUs) in the United Kingdom. The trial derives from the need for a large, pragmatic RCT to determine the optimal route of delivery for early nutritional support in the critically ill. ⋯ In keeping with best trial practice, we have developed, described and published a statistical analysis plan for the CALORIES trial and are placing it in the public domain before inspecting data from the trial.
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Observational Study
The association of plasma gammaaminobutyric acid concentration with postoperative delirium in critically ill patients.
Delirium is a common complication in postoperative, critically ill patients. The mechanism of postoperative delirium is not well understood but many studies have shown significant associations between benzodiazepine use, alcohol withdrawal and cirrhosis, and an increased risk of delirium. We aimed to investigate a possible link with alterations of gamma-aminobutyric acid (GABA) activity. ⋯ Plasma GABA level on POD 2 has a significant independent association with postoperative delirium.
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To determine the proportion of computed tomography pulmonary angiograms (CTPAs), performed after medical emergency team (MET) calls, that are positive for pulmonary embolism (PE), and whether there are useful clinical predictors of positive CTPA results. ⋯ Clinical decision rules and MET indications were not significantly associated with the presence of PE on CTPA. However, an abnormal chest x-ray has a high negative predictive value and therefore may be helpful in preventing unnecessary CTPAs.