Articles: critical-care.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial.
Findings from preclinical studies and one pilot clinical trial suggest potential benefits of epidural analgesia in acute pancreatitis. We aimed to assess the efficacy of thoracic epidural analgesia, in addition to usual care, in improving clinical outcomes of intensive care unit patients with acute pancreatitis. ⋯ In a population of intensive care unit adults with acute pancreatitis and low requirement for intubation, this first multicenter randomized trial did not show the hypothesized benefit of epidural analgesia in addition to usual care. Safety of epidural analgesia in this setting requires further investigation.
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Randomized Controlled Trial
Effectiveness of techniques for insertion of nasoenteral probe in critical patients: Randomized clinical trial.
despite being a common procedure, nasally placed small-bowel feeding tube insertion is not risk-free and can compromise patient safety. Due to the fact that nasally placed small-bowel feeding tube is commonly inserted '"blindly," with the patient head in the neutral position, sometimes the process becomes difficult and traumatic, and may present higher level of complexity in physiological or induced coma and intubated patients. Therefore, adverse events (AEs) route errors can occur during this procedure. This study aimed to determine the effectiveness of different nasally placed small-bowel feeding tube insertion techniques in coma and intubated patients, in comparison with conventional method. ⋯ A prospective, randomized and controlled clinical trial will be carried out with coma and intubated patients admitted to the Intensive Care Unit (ICU). Thirty-nine patients will be randomly divided into 3 groups: group who will have the tube inserted in a conventional manner with the head in the neutral position, group with the head positioned laterally to the right, and, finally, with the head in the neutral position, with assistance of a laryngoscope. The primary endpoint will be: first, second and total attempt success rate; and time required for the first successful attempt and the sum of all attempts. Complications during insertion included tube bending, twisting, knotting, mucosal bleeding, and insertion into the trachea. Patient vital signs will be measured.
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Randomized Controlled Trial
Effect of total cholesterol and statin therapy on mortality in ARDS patients: a secondary analysis of the SAILS and HARP-2 trials.
Two acute respiratory distress syndrome (ARDS) trials showed no benefit for statin therapy, though secondary analyses suggest inflammatory subphenotypes may have a differential response to simvastatin. Statin medications decrease cholesterol levels, and low cholesterol has been associated with increased mortality in critical illness. We hypothesized that patients with ARDS and sepsis with low cholesterol could be harmed by statins. ⋯ Cholesterol levels are low in two cohorts with sepsis-related ARDS, and those in the lowest cholesterol quartile are sicker. Despite the very low levels of cholesterol, simvastatin therapy seems safe and may reduce mortality in this group, though rosuvastatin was associated with harm.
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Critical care medicine · Mar 2023
Randomized Controlled Trial Multicenter StudyImproving ICU Risk Predictive Models Through Automation Designed for Resiliency Against Documentation Bias.
Electronic health records enable automated data capture for risk models but may introduce bias. We present the Philips Critical Care Outcome Prediction Model (CCOPM) focused on addressing model features sensitive to data drift to improve benchmarking ICUs on mortality performance. ⋯ These mortality risk models demonstrated excellent performance compared with APACHE while appearing to mitigate bias introduced through major shifts in GCS documentation at two large health systems. This provides evidence to support using automated capture rather than trained personnel for capture of GCS data used in benchmarking ICUs on mortality performance.
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Randomized Controlled Trial
Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial.
In critically ill patients, positive fluid balance is associated with excessive mortality. The POINCARE-2 trial aimed to assess the effectiveness of a fluid balance control strategy on mortality in critically ill patients. ⋯ The POINCARE-2 conservative strategy did not reduce mortality in critically ill patients. However, due to open-label and stepped wedge design, intention-to-treat analyses might not reflect actual exposure to this strategy, and further analyses might be required before completely discarding it. Trial registration POINCARE-2 trial was registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.