The Effect of SPecialty cAre on Recovery From Cardiac Arrest Trial (the SPARC Trial)

Обзор

This randomized clinical trial will determine if adult participants who are in the emergency department after being resuscitated from a cardiac arrest outside of the hospital benefit from care delivered at specialized centers. The main question that it will answer is whether transferring participants to a hospital with a specialized cardiac arrest service improves recovery of function after 90 days. Participants will receive all usual medical care, but some participants will be offered transfer to a regional cardiac arrest center and others will be offered care at the closest appropriate hospital. Investigators will interview participants after 90 days to assess their recovery.

Подробное описание

Cardiac arrest is a sudden stopping of the heart, which can sometimes be reversed by rapid cardiopulmonary resuscitation (CPR) and emergency medical care. Each year, over 150,000 Americans are admitted to the hospital after receiving CPR. However, many of these patients die in the hospital. There is wide variation in patient outcomes between hospitals. A key knowledge gap about systems of care is whether specific hospital or subsequent interventions or processes of care are associated with better patient outcomes. Specifically, it is unknown if patient outcomes are improved by specialized centers or by improved implementation of recommended interventions at all hospitals.

Observational data in our region and internationally suggest that out-of-hospital cardiac arrest outcomes are better when patients who survive CPR are hospitalized in specialty care or high-volume centers. It is unclear from these studies what are the minimal capabilities that distinguish specialty care from usual care and which aspects of specialty care are influencing outcomes.

This trial will take advantage of a regional system of care that includes 18 hospitals in southwestern Pennsylvania that treat over 1,000 patients resuscitated from out-of-hospital cardiac arrest annually. This region includes one high-volume specialty center with specific attention to recommended interventions for this patient population, as well as several secondary and tertiary care facilities with variable resources and approaches to patient care. This randomized trial will compare outcomes for patients assigned to care at the specialty center versus other centers and will leverage the heterogeneity of treatment between centers to understand the influence of specific treatments.

Вмешательства

• Другое Transfer to specialty care
  Interfacility transport and treatment at the specialty care hospital
• Другое Usual care
  Hospitalization and treatment at the closest appropriate facility

Первичные конечные точки

• Modified Rankin Scale [Срок оценки: 90 Days post arrest]

Вторичные конечные точки (3)

• Survival to ICU Admission [Срок оценки: 24 hours post arrest]
• 72 hour survival [Срок оценки: 72 hours post arrest]
• mRS at hospital discharge [Срок оценки: Up to 6 months post arrest]

Критерии участия

Критерии включения

• Out-of-hospital cardiac arrest
• Resuscitated from cardiac arrest with palpable pulse in the emergency department
• Treated at one of participating hospital emergency departments
• Age ≥18 years

Критерии исключения

• Known prior advanced directives or decision to limit critical care
• Known pre-arrest dependent functional status (e.g., living in a skilled nursing facility, hospice or bedbound)
• Arrest in the emergency department >4 hours after arrival
• Traumatic etiology of arrest
• Known to have opted-out from the SPARC trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh Department of Emergency Medicine — Pittsburgh

Публикации

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• Elmer J, Molyneaux BJ, Shutterly K, Stuart SA, Callaway CW, Darby JM, Weisgerber AR. Organ donation after resuscitation from cardiac arrest. Resuscitation. 2019 Dec;145:63-69. doi: 10.1016/j.resuscitation.2019.10.013. Epub 2019 Oct 22. PMID 31654724
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• VanderWeele TJ. Commentary: On Causes, Causal Inference, and Potential Outcomes. Int J Epidemiol. 2016 Dec 1;45(6):1809-1816. doi: 10.1093/ije/dyw230. No abstract available. PMID 28130319
• Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173. PMID 3806354

Идентификаторы

NCT: NCT07002294 · STUDY25050152 · R61HL175113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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