The Effect of SPecialty cAre on Recovery From Cardiac Arrest Trial (the SPARC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,618
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Transfer to specialty care
Participants randomized to receive specialty care will undergo immediate interfacility transport to and hospital treatment at the specialty care hospital
干预措施: Transfer to specialty care (Other)
Usual care
Participants randomized to the usual care arm will be hospitalized at the first hospital or transferred to the closest appropriate hospital
干预措施: Usual care (Other)
结局指标
主要结局
Modified Rankin Scale
时间窗: 90 Days post arrest
The Modified Rankin Scale (mRS) is a measure of functional recovery, measured 90 days after cardiac arrest. A Modified Rankin Score (mRS) of 0 corresponds to full functional recovery and a Modified Rankin Score (mRS) of 6 corresponds to death, with progressively worse functional outcomes at higher scores. Intermediate values reflect progressive functional dependence, with higher scores reflecting greater dependence on others.
Modified Rankin Scale
时间窗: 90 Days post arrest
The Modified Rankin Scale (mRS) is a measure of functional recovery, measured 90 days after cardiac arrest. A Modified Rankin Score (mRS) of 0 corresponds to full functional recovery and a Modified Rankin Score (mRS) of 6 corresponds to death, with progressively worse functional outcomes at higher scores. Intermediate values reflect progressive functional dependence, with higher scores reflecting greater dependence on others.
次要结局
- Survival to ICU Admission(24 hours post arrest)
- 72 hour survival(72 hours post arrest)
- mRS at hospital discharge(Up to 6 months post arrest)
研究者
Jonathan Elmer
Associate Professor
University of Pittsburgh