Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial

Acta Anaesthesiologica Scandinavica, Год журнала: 2025, Номер 69(5)

Опубликована: Апрель 3, 2025

Abstract Background Sedation is often provided to resuscitated out‐of‐hospital cardiac arrest (OHCA) patients tolerate post‐cardiac care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after limited. The aim this trial investigate effects continuous compared minimal on patient‐important outcomes in OHCA a large clinical trial. Methods SED‐CARE part 2 × factorial Sedation, Temperature and Pressure Cardiac Arrest Resuscitation (STEPCARE) trial, randomized international, multicentre, parallel‐group, investigator‐initiated, superiority with three simultaneous intervention arms. In adults sustained return spontaneous circulation (ROSC) who are comatose following resuscitation will be within 4 hours (Richmond agitation scale (RASS) −4/−5) ( ) (RASS 0 −2) comparator ), for 36 h ROSC. primary outcome all‐cause mortality at 6 months randomization. two other components STEPCARE evaluate control strategies. Apart interventions, all aspects general intensive care according local practices participating site. Neurological prognostication performed European Council Society Intensive Care Medicine guidelines by physician blinded allocation group. To detect an absolute risk reduction 5.6% alpha 0.05, 90% power, 3500 participants enrolled. secondary proportion poor functional randomization, serious adverse events unit, patient‐reported overall health status Conclusion if confers arrest.

Язык: Английский

Fever management with or without a temperature control device after out‐of‐hospital cardiac arrest and resuscitation (TEMP‐CARE): A study protocol for a randomized clinical trial

Acta Anaesthesiologica Scandinavica, Год журнала: 2025, Номер 69(5)

Опубликована: Апрель 13, 2025

Fever is associated with brain injury after cardiac arrest. It unknown whether fever management a feedback-controlled device impacts patient-centered outcomes in arrest patients. This trial aims to investigate or without temperature control out-of-hospital The TEMP-CARE part of the 2 × factorial Sedation, TEmperature and Pressure Cardiac Arrest REsuscitation (STEPCARE) trial, randomized, international, multicenter, parallel-group, investigator-initiated, superiority that will evaluate sedation strategies, management, blood pressure targets simultaneously nontraumatic/nonhemorrhagic patients following hospital admission. For component described this protocol, be randomly allocated device. those managed device, if ≥37.8°C occurs within 72 h post-randomization started targeting ≤37.5°C. Standard treatment, as recommended by local guidelines, including pharmacological agents, provided participants both groups. two other components STEPCARE strategies. Apart from interventions, all aspects general intensive care according practices participating site. A physician blinded intervention determine neurological prognosis European Resuscitation Council Society Intensive Care Medicine guidelines. primary outcome all-cause mortality at six months post-randomization. To detect 5.6% absolute risk reduction (90% power, alpha .05), 3500 enrolled. Secondary include poor functional months, care-related serious adverse events, overall health status months. post-cardiac affects patient-important

Язык: Английский

Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP‐CARE): A protocol for a randomized clinical trial

Acta Anaesthesiologica Scandinavica, Год журнала: 2025, Номер 69(6)

Опубликована: Май 20, 2025

Abstract Background In patients resuscitated after cardiac arrest, a higher mean arterial pressure (MAP) may increase cerebral perfusion and attenuate hypoxic brain injury. Here we present the protocol of arrest resuscitation (MAP‐CARE) trial aiming to investigate influence MAP targets on patient outcomes. Methods ‐ CARE is one component Sedation, Temperature Pressure Cardiac Arrest Resuscitation ( STEPCARE ) 2 x factorial randomized trial. The an international, multicenter, parallel‐group, investigator‐initiated, superiority designed test hypothesis that targeting (>85 mmHg intervention versus lower (>65 comparator from reduces 6‐month mortality primary outcome ). Trial participants are adults with sustained return spontaneous circulation who comatose following out‐of‐hospital arrest. two other components evaluate sedation temperature control strategies. Apart interventions, all aspects general intensive care will be according local practices participating site. Neurological prognostication performed European Council Society Intensive Care Medicine guidelines by physician blinded allocation group. sample size 3500 provides 90% power alpha 0.05 detect 5.6 absolute risk reduction in mortality, assuming 60% Secondary outcomes poor functional 6 months randomization, patient‐reported overall health proportion predefined severe adverse events. Conclusion MAP‐CARE if compared during mortality.

Язык: Английский