Acta anaesthesiologica Scandinavica
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Acta Anaesthesiol Scand · May 2020
Randomized Controlled Trial Multicenter StudyEfficacy and safety of iloprost in patients with septic shock-induced endotheliopathy - protocol for the multicenter randomized, placebo-controlled, blinded, investigator-initiated COMBAT-SHINE trial.
In Europe 700.000 new cases of sepsis occur annually and more than 100.000 of these patients die due to multiorgan failure (MOF). We have identified shock-induced endotheliopathy (SHINE) to be associated with development of MOF and mortality. Furthermore, in patients with septic shock those with circulating levels of thrombomodulin (TM) above 10 ng/mL have twice the mortality (56% vs 28%) than those with levels below this level. Pilot studies indicate that infusion of iloprost (1 ng/kg/min) is associated with improved endothelial function in patients with septic shock. ⋯ This trial tests the safety and efficacy of iloprost vs placebo for 72 hours in patients with septic shock and SHINE. The outcome measures focus on the potential effect of the intervention to mitigate organ failure.
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Acta Anaesthesiol Scand · Apr 2020
Randomized Controlled Trial Multicenter StudyHypothermic to ischaemic ratio and mortality in post cardiac arrest patients.
We studied the associations between ischemia and hypothermia duration, that is, the hypothermic to ischemic ratio (H/I ratio), with mortality in patients included in a trial on two durations of targeted temperature management (TTM) at 33°C. ⋯ We did not find any consistent evidence of a modification of the effect of TTM based on ischemia duration.
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Acta Anaesthesiol Scand · Mar 2020
Randomized Controlled Trial Multicenter StudyHyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events: Protocol for a 2x2 factorial randomised clinical trial.
Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days. ⋯ The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.
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Acta Anaesthesiol Scand · Feb 2020
Randomized Controlled Trial Multicenter StudyDEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty. A protocol for a randomized, blinded, three-group multicentre clinical trial.
Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists. ⋯ Recruiting is planned to commence September 2018 and expected to finish March 2020.
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Acta Anaesthesiol Scand · Feb 2020
Randomized Controlled Trial Multicenter StudyBenefits and harm of paracetamol and ibuprofen in combination for postoperative pain: preplanned subgroup analyses of the multicenter randomized PANSAID trial.
The "Paracetamol and Ibuprofen in Combination" (PANSAID) trial showed that combining paracetamol and ibuprofen resulted in lower opioid consumption than each drug alone and we did not find an increase in risk of harm when using ibuprofen vs paracetamol. The aim of this subgroup analysis was to investigate the differences in benefits and harms of the interventions in different subgroups. We hypothesized that the intervention effects would differ in subgroups with different risk of pain or adverse events. ⋯ These pre-planned subgroup analyses did not suggest that patients in the investigated subgroups benefitted differently from a basic non-opioid analgesic regimen consisting of paracetamol and ibuprofen. Further, there was no evidence of subgroup heterogeneity regarding harm and use of ibuprofen. Because of reduced statistical power in subgroup analyses, we cannot exclude clinically relevant subgroup heterogeneity.