return of spontaneous circulation
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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 the mean arterial pressure after cardiac arrest and resuscitation (MAP-CARE) trial aiming to investigate the influence of MAP targets on patient outcomes. METHODS: MAP-CARE is one component of the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) 2 x 2 x 2 factorial randomized trial. The MAP-CARE trial is an international, multicenter, parallel-group, investigator-initiated, superiority trial designed to test the hypothesis that targeting a higher (>85 mmHg) (intervention) versus a lower (>65 mmHg) (comparator) MAP after resuscitation from cardiac arrest reduces 6-month mortality (primary outcome). Trial participants are adults with sustained return of spontaneous circulation who are comatose following resuscitation from out-of-hospital cardiac arrest. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to allocation group. The sample size of 3500 participants provides 90% power with an alpha of 0.05 to detect a 5.6 absolute risk reduction in 6-month mortality, assuming a mortality of 60% in the control group. Secondary outcomes will be poor functional outcome 6 months after randomization, patient-reported overall health 6 months after randomization, and the proportion of participants with predefined severe adverse events. CONCLUSION: The MAP-CARE trial will investigate if targeting a higher MAP compared to a lower MAP during intensive care of adults who are comatose following resuscitation from out-of-hospital cardiac arrest reduces 6-month mortality.
- MeSH
- arteriální tlak * fyziologie MeSH
- dospělí MeSH
- hodnocení ekvivalence jako téma MeSH
- kardiopulmonální resuscitace * metody MeSH
- kóma etiologie MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- randomizované kontrolované studie jako téma MeSH
- resuscitace * MeSH
- srdeční zástava * terapie patofyziologie mortalita MeSH
- výsledek terapie MeSH
- zástava srdce mimo nemocnici * terapie patofyziologie mortalita MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial. METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization. CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.
- MeSH
- analgosedace * metody MeSH
- dospělí MeSH
- hluboká sedace * metody MeSH
- kardiopulmonální resuscitace * metody MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- zástava srdce mimo nemocnici * terapie mortalita MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- srovnávací studie MeSH
The increased accessibility of extracorporeal membrane oxygenation following the COVID-19 pandemic and the publication of the first randomized trial of extracorporeal cardiopulmonary resuscitation (ECPR) prompted the National Heart, Lung, and Blood Institute to sponsor a workshop on ECPR. Two more randomized trials have since been published in 2022 and 2023. Based on the combined findings and review of the evidence, an international panel of authors identified gaps in science, inequities in care and diversity in outcomes, and suggested research opportunities and next steps. The science pertaining to ECPR would benefit from the United States contributing uniform data to existing registries and sharing common data with the ELSO (Extracorporeal Life Support Organization) international registry to increase the sample size for observational research. In addition, well-designed efficacy trials, recruiting across different regions of care evaluating long-term follow-up, including patient reported outcomes, cost effectiveness, and equity measures, would contribute significantly to the body of science. Workshop participants defined the population of patients with out-of-hospital cardiac arrest most likely to benefit from ECPR. ECPR-eligible patients include those aged 18 to 75 years functioning independently without comorbidity; before suffering a witnessed out-of-hospital cardiac arrest and without any obvious cause of the cardiac arrest; presenting in a shockable rhythm and transported with mechanical cardiopulmonary resuscitation to an ECPR-capable institute within 30 minutes, which is recommended after 3 rounds of advanced life support treatment without return of spontaneous circulation. There are significant inequities in out-of-hospital cardiac arrest care that need to be addressed such that outcomes are optimized for each target region before implementing ECPR in a clinical or implementation trial.
- MeSH
- COVID-19 epidemiologie terapie MeSH
- kardiopulmonální resuscitace * metody MeSH
- konsensus MeSH
- lidé MeSH
- mezery v důkazech MeSH
- mimotělní membránová oxygenace * metody MeSH
- National Heart, Lung, and Blood Institute (U.S.) * MeSH
- SARS-CoV-2 MeSH
- zástava srdce mimo nemocnici * terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Spojené státy americké MeSH
OBJECTIVE: The epidemiology of pediatric cardiac arrest in Europe is largely unknown. We aimed to characterize pediatric cardiac arrest registries and obtain the first survival outcome data on pediatric cardiac arrest in Europe. DESIGN: This is a prospective multinational survey. SETTING: We surveyed all 53 countries in Europe asking about: the existence registries for pediatric out-of-hospital cardiac arrest (pOHCA) and/or in-hospital cardiac arrest (pIHCA)), the data collected, and the structure of the registries. Subsequently, we investigated outcomes (number of pOHCA/pIHCA since start of the registry, return of spontaneous circulation (ROSC), survival to hospital discharge/30-day survival) from the countries with active registries. PATIENTS AND INTERVENTIONS: We obtained information from 33 countries including 25 of the 27 European Union states. MEASUREMENTS AND MAIN RESULTS: Thirteen countries (39%) have an ongoing pediatric cardiac arrest registry (pOHCA: 11 countries, pIHCA: 8 countries). All use the Utstein template for data collection. Five countries (15%) collect data about CPR quality. Eleven countries (33%) expressed interest in European collaboration on registry data. Overall, 13 countries reported data on outcomes from a total of 17,708 pOHCAs and 2,743 pIHCAs. The ROSC rate after pOHCA ranges from 10% to 72% as compared to 60% to 72% after pIHCA. Survival to hospital discharge ranges from 16% to 39% after pOHCA as compared to 32% to 57% after pIHCA. CONCLUSIONS: Less than 40% of the European countries have a pOHCA and/or pIHCA registry, reporting a wide variety in survival rates, especially after pOHCA. More systematic data collection is needed to identify the real incidence and outcomes from pediatric cardiac arrest, ideally through a joint European registry.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Adrenaline (ADR) is a cornerstone of advanced life support (ALS) in cardiac arrest (CA), although its neurologically favourable survival outcomes remain unclear. ADR increases coronary perfusion pressure (CPP), with levels >15 mmHg associated with successful defibrillation. This study aimed to elucidate the relationship between ADR, myocardial microvascular blood flow, and resuscitation outcomes using a porcine CA model simulating refractory ventricular fibrillation (VF). METHODS: This study involved 24 domestic pigs. After instrumentation, intubation, and baseline measurements, the animals were randomised into the ADR or control (saline) groups. VF was induced, and cardiopulmonary resuscitation was initiated using continuous mechanical chest compressions and ventilation. ADR or saline was administered following ALS guidelines. After 21 min of ALS, defibrillation was performed. Continuous measurements of arterial and venous blood pressures using an electrocardiogram and index of myocardial resistance (IMR) and transit mean time (Tmn) 1 min before and after each injection or peak blood pressure were recorded and compared between the groups. CPP-IMR, amplitude spectrum area (AMSA)-IMR, CPP-Tmn, and AMSA-Tmn correlations were assessed. RESULTS: Compared with six animals in the control group, three in the ADR group achieved a return of spontaneous circulation. No difference was observed in IMR or AMSA; however, significant increases in CPP and arterial end-diastolic blood pressure were observed at several time points. Tmn differed between groups only at two time points. CONCLUSION: Repeated ADR doses during prolonged ALS simulating refractory VF did not improve myocardial microvascular blood flow, as measured using IMR, despite leading to an increase in CPP.
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: Airway management is a critical component of out-of-hospital cardiac arrest (OHCA) resuscitation. The primary aim of this study was to describe pre-hospital airway management in adult patients post-OHCA. Secondary aims were to investigate whether tracheal intubation (TI) versus use of supraglottic airway device (SGA) was associated with patients' outcomes, including ventilator-free days within 26 days of randomization, 6 months neurological outcome and mortality. METHODS: Secondary analysis of the Target Temperature Management-2 (TTM2) trial conducted in 13 countries, including adult patients with OHCA and return of spontaneous circulation, with data available on pre-hospital airway management. A multivariate logistic regression model with backward stepwise selection was employed to assess whether TI versus SGA was associated with outcomes. RESULTS: Of the 1900 TTM2 trial patients, 1702 patients (89.5%) were included, with a mean age of 64 years (Standard Deviation, SD = 13.53); 79.1% were males. Pre-hospital airway management was SGA in 484 (28.4%), and TI in 1218 (71.6%) patients. At hospital admission, 87.8% of patients with SGA and 98.5% with TI were mechanically ventilated (p < 0.001). In the multivariate analysis, TI in comparison with SGA was not independently associated with an increase in ventilator-free days within 26 days of randomization, improved neurological outcomes, or decreased mortality. The hazard ratio for mortality with TI vs. SGA was 1.06, 95%Confidence Interval (CI) 0.88-1.28, p = 0.54. CONCLUSIONS: In the multicentre randomized TTM2-trial including patients with OHCA, most patients received prehospital endotracheal intubation to manage their airway. The choice of pre-hospital airway device was not independently associated with patient clinical outcomes. TRIAL REGISTRATION NUMBER: NCT02908308.
- MeSH
- intratracheální intubace * metody MeSH
- kardiopulmonální resuscitace * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- terapeutická hypotermie metody MeSH
- urgentní zdravotnické služby * metody MeSH
- zajištění dýchacích cest * metody MeSH
- zástava srdce mimo nemocnici * terapie mortalita MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Induced hypothermia post-cardiac arrest is neuroprotective in animal experiments, but few high-quality studies have been performed in larger animals with human-like brains. The neuroprotective effect of postischemic hypothermia has recently been questioned in human trials. Our aim is to investigate whether hypothermia post-cardiac arrest confers a benefit compared to normothermia in large adult animals. Our hypothesis is that induced hypothermia post cardiac arrest is neuroprotective and that the effect diminishes when delayed two hours. METHODS: Adult female pigs were anesthetized, mechanically ventilated and kept at baseline parameters including normothermia (38 °C). All animals were subjected to ten minutes of cardiac arrest (no-flow) by induced ventricular fibrillation, followed by four minutes of cardiopulmonary resuscitation with mechanical compressions, prior to the first countershock. Animals with sustained return of spontaneous circulation (systolic blood pressure >60 mmHg for ten minutes) within fifteen minutes from start of life support were included and randomized to three groups; immediate or delayed (2 h) intravenous cooling, both targeting 33 °C, or intravenously controlled normothermia (38 °C). Temperature control was applied for thirty hours including cooling time, temperature at target and controlled rewarming (0.5 °C/h). Animals were extubated and kept alive for seven days. The primary outcome measure is histological brain injury on day seven. Secondary outcomes include neurological and neurocognitive recovery, and the trajectory of biomarkers of brain injury. CONCLUSION: High-quality animal experiments in clinically relevant large animal models are necessary to close the gap of knowledge regarding neuroprotective effects of induced hypothermia after cardiac arrest.Trial registration:Preclinicaltrials.eu (PCTE0000272), published 2021-11-03.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Randomized data evaluating the impact of the extracorporeal cardiopulmonary resuscitation (ECPR) approach on long-term clinical outcomes in patients with refractory out-of-hospital cardiac arrest (OHCA) are lacking. The objective of this follow-up study was to assess the long-term clinical outcomes of the ECPR-based versus CCPR approach. METHODS: The Prague OHCA trial was a single-center, randomized, open-label trial. Patients with witnessed refractory OHCA of presumed cardiac origin, without return of spontaneous circulation, were randomized during ongoing resuscitation on scene to conventional CPR (CCPR) or an ECPR-based approach (intra-arrest transport, ECPR if ROSC is not achieved prehospital and immediate invasive assessment). RESULTS: From March 2013 to October 2020, 264 patients were randomized during ongoing resuscitation on scene, and 256 patients were enrolled. Long-term follow-up was performed 5.3 (interquartile range 3.8-7.2) years after initial randomization and was completed in 255 of 256 patients (99.6%). In total, 34/123 (27.6%) patients in the ECPR-based group and 26/132 (19.7%) in the CCPR group were alive (log-rank P = 0.01). There were no significant differences between the treatment groups in the neurological outcome, survival after hospital discharge, risk of hospitalization, major cardiovascular events and quality of life. Of long-term survivors, 1/34 (2.9%) in the ECPR-based arm and 1/26 (3.8%) in the CCPR arm had poor neurological outcome (both patients had a cerebral performance category score of 3). CONCLUSIONS: Among patients with refractory OHCA, the ECPR-based approach significantly improved long-term survival. There were no differences in the neurological outcome, major cardiovascular events and quality of life between the groups, but the trial was possibly underpowered to detect a clinically relevant difference in these outcomes. Trial registration ClinicalTrials.gov Identifier: NCT01511666, Registered 19 January 2012.
- MeSH
- časové faktory MeSH
- kardiopulmonální resuscitace * MeSH
- kvalita života MeSH
- lidé MeSH
- následné studie MeSH
- retrospektivní studie MeSH
- zástava srdce mimo nemocnici * terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Delayed hypothermia, initiated after hospital arrival, several hours after cardiac arrest with 8-10 hours to reach the target temperature, is likely to have limited impact on overall survival. However, the effect of ultrafast hypothermia, i.e., delivered intra-arrest or immediately after return of spontaneous circulation (ROSC), on functional neurologic outcome after out-of-hospital cardiac arrest (OHCA) is unclear. In two prior trials, prehospital trans-nasal evaporative intra-arrest cooling was safe, feasible and reduced time to target temperature compared to delayed cooling. Both studies showed trends towards improved neurologic recovery in patients with shockable rhythms. The aim of the PRINCESS2-study is to assess whether cooling, initiated either intra-arrest or immediately after ROSC, followed by in-hospital hypothermia, significantly increases survival with complete neurologic recovery as compared to standard normothermia care, in OHCA patients with shockable rhythms. METHODS/DESIGN: In this investigator-initiated, randomized, controlled trial, the emergency medical services (EMS) will randomize patients at the scene of cardiac arrest to either trans-nasal cooling within 20 minutes from EMS arrival with subsequent hypothermia at 33°C for 24 hours after hospital admission (intervention), or to standard of care with no prehospital or in-hospital cooling (control). Fever (>37,7°C) will be avoided for the first 72 hours in both groups. All patients will receive post resuscitation care and withdrawal of life support procedures according to current guidelines. Primary outcome is survival with complete neurologic recovery at 90 days, defined as modified Rankin scale (mRS) 0-1. Key secondary outcomes include survival to hospital discharge, survival at 90 days and mRS 0-3 at 90 days. In total, 1022 patients are required to detect an absolute difference of 9% (from 45 to 54%) in survival with neurologic recovery (80% power and one-sided α=0,025, β=0,2) and assuming 2,5% lost to follow-up. Recruitment starts in Q1 2024 and we expect maximum enrolment to be achieved during Q4 2024 at 20-25 European and US sites. DISCUSSION: This trial will assess the impact of ultrafast hypothermia applied on the scene of cardiac arrest, as compared to normothermia, on 90-day survival with complete neurologic recovery in OHCA patients with initial shockable rhythm. TRIAL REGISTRATION: NCT06025123.
- MeSH
- časové faktory MeSH
- elektrická defibrilace metody MeSH
- kardiopulmonální resuscitace metody MeSH
- lidé MeSH
- obnova funkce * MeSH
- obnovení spontánní cirukulace MeSH
- terapeutická hypotermie * metody MeSH
- urgentní zdravotnické služby * metody MeSH
- zástava srdce mimo nemocnici * terapie mortalita MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
- randomizované kontrolované studie MeSH
