Acta anaesthesiologica Scandinavica
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Acta Anaesthesiol Scand · Oct 2019
Randomized Controlled TrialConservative versus Liberal fluid therapy in Septic Shock (CLASSIC) trial - protocol and statistical analysis plan.
Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock. ⋯ The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.
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Acta Anaesthesiol Scand · Oct 2019
Randomized Controlled Trial Multicenter StudyPantoprazole in ICU patients at risk for gastrointestinal bleeding - one-year mortality in the SUP-ICU trial.
The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial. ⋯ We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis with pantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).
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Acta Anaesthesiol Scand · Oct 2019
Randomized Controlled TrialIntraoperative methadone for postoperative pain after laparoscopic hysterectomy: Protocol for a randomised, double-blind trial.
Hysterectomy is often carried out as same-day surgery. Treatment of postoperative pain is, therefore, of utmost importance to ensure timely discharge from hospital. Methadone has several desirable pharmacological features, including a long elimination half-life. Theoretically, a single intraoperative dose could provide long-lasting pain relief. ⋯ The study outlined in this protocol will provide important information about the use of methadone in same-day hysterectomy patients. The results will presumably be applicable to other types of surgery involving visceral pain.
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Acta Anaesthesiol Scand · Oct 2019
Randomized Controlled Trial Multicenter StudyLower versus higher transfusion threshold in septic shock patients of different ages: a study protocol.
Current evidence indicates that it is safe to use a lower haemoglobin (Hb) threshold for red blood cell (RBC) transfusion as compared to a higher Hb-threshold. However, the recent Transfusion Requirements in Cardiac Surgery (TRICS-3) trial reported a significant interaction between patient age and the effect of lower vs higher Hb-thresholds for RBC transfusion. The interaction between patient age and transfusion strategy appears to differ between trials. ⋯ The outlined study will make a detailed assessment of potential interaction of patient age with transfusion strategy in patients with septic shock. This may inform future trials on the benefits and harms of RBC transfusion.
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Acta Anaesthesiol Scand · Oct 2019
Randomized Controlled Trial Multicenter Study Observational StudyCerebrovascular autoregulation following cardiac arrest: protocol for a post hoc analysis of the randomized COMACARE pilot trial.
Approximately two-thirds of the mortality following out of hospital cardiac arrest is related to devastating neurological injury. Previous small cohort studies have reported an impaired cerebrovascular autoregulation following cardiac arrest, but no studies have assessed the impact of differences in oxygen and carbon dioxide tensions in addition to mean arterial pressure management. ⋯ Cerebrovascular autoregulation is critical to maintain homoeostatic brain perfusion. This study of changes in autoregulation following out of hospital cardiac arrest over the first 48 hours, as compared to data from healthy volunteers, will generate important physiological information that may guide the rationale and design of interventional studies.