ICU treatment after a cardiac arrest optimal treatment after cardiac arrest
Conditions
Interventions
Screening and randomization
Screening can be performed either in the emergency room, angiography suite, or
in the ICU. Clinical investigators at each participating site will be
responsible for scree
Sponsors
Department ofAnesthesiology and IntensiveCare, Helsingborg Hospital Department of Clinical Sciences, Lund University, Faculty of Medicine
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Out-of-hospital cardiac arrest of non-traumatic origin 2. A minimum of 20 minutes without chest compressions* 3. Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of
Exclusion criteria
Exclusion criteria: 1. On ECMO prior to randomization 2. Pregnancy 3. Suspected or confirmed intracranial hemorrhage 4. Previously randomized in the STEPCARE trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will investigate the following main hypotheses: • In adults who are comatose following resuscitation from out-of-hospital cardiac arrest continuous sedation for 36 hours leads to lower six-month mortality than minimal se-dation. • In adults who are comatose following resuscitation from out-of-hospital cardiac arrest, fever management with a device leads to a lower mortality than fever management without a feedback-controlled device. • In adults who are comatose following resuscitation from out-of-hospital cardiac arrest, targeting a mean arterial pressure of >85 mmHg leads to a lower mortality than target-ing a mean arterial pressure of >65 mmHg. Primary Outcome: All-cause mortality assessed at 6 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of participants with a poor functional outcome measured in either one of two ways (hierarchical order): 1.Using the clinician reported modified Rankin Scale (mRS)-scale (mRS 4-6) at 6 months after randomization 2. If a score cannot be assigned using the standardized assessment patients with be categorized based on whether they are found to be dependent on others for basic ac-tivities of daily life (moving indoors, eating, dressing, personal hygiene) • Patient reported Health-Related Quality of Life (HRQoL) using EQ5D-5L including EQVAS at 6 months after randomization. • Proportion of patients who had a pre-defined safety event or death in the ICU. (For each trial) o SED-CARE: sepsis or septic shock (Sepsis III criteria), arrhythmia requiring defibrillation, cardioversion or chest compressions, venous thromboembolism,reintubation, non-planned extubation o TEMP-CARE: sepsis or septic shock (Sepsis III criteria), arrhythmia requiring defibrillation, cardioversion or chest compressions, venous thromboembolism, moderate or severe bleed-ing (GUSTO criteria) o MAP-CARE: arrhythmia requiring defibrillation, cardioversion or chest compressions, mod-erate or severe bleeding (GUSTO criteria), acute kidney injury with renal replacement thera-py, limb ischemia requiring radiological or surgical intervention, or gut ischemia demonstrated at laparotomy/laparoscopy or clinically suspected based on abdominal CT-scan or in the con-text of palliative management. Exploratory outcomes • Ventilator free days within the first 30 days • Hospital/institution free days alive within the first 30 days | — |
Countries
Netherlands
Outcome results
None listed