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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02164851
Non-Invasive Shock: Differentiating Shock in the Emergency Department (NIS)
Visão geral do estudo
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Descrição detalhada
Shock is a common final pathway for many disease states, occurring when oxygen and nutrient delivery are not sufficient to maintain normal cellular function. The incidence of shock in the emergency department (ED) is approximated to be 1-3% of ED patients(1), and it carries a high mortality, ranging from 20-50% depending on the underlying cause of shock(2). Early recognition and treatment of shock significantly improves outcomes in critically ill patients(2, 3), and so the majority of efforts to this point have focused on identifying patients with shock.
The many etiologies of shock may be grouped into several broader categories: cardiogenic, distributive, hemorrhagic, hypovolemic, anaphylactic, and neurogenic. These categories cause shock through different mechanisms, but they have a significant amount of clinical overlap (4-7), making differentiating the cause of shock challenging for the emergency provider. While some overlap also exists between the treatments for these categories, several have vastly different therapeutic approaches. Since the early treatment of shock influences outcomes(2, 3, 8, 9), identifying the correct etiology to treat should logically impact outcomes as well, although this has not been studied in shock patients. However, Moore, et al., did show that physicians were only able to correctly identify the cause of hypotension in 25% of hypotensive patients in the ED, speaking to both the difficulty in diagnosing shock etiologies and the high percentage of patients with undifferentiated shock(10).
Recently, a number of different devices and biomarkers have been suggested to have clinical utility in differentiating shock and guiding resuscitation(11-13). These devices have potential to aid in the differentiation of shock.
We will conduct a prospective, observational study of patients found to have shock and "near-shock" physiology in the emergency department. We will identify patients meeting our inclusion criteria which will identify shock and "near shock" patients. Inclusion criteria will include: HR > 120, SBP < 90, or a shock index (HR/SBP) > 1 for at least five minutes. Patients that do meet vital sign requirements, but have a lactate > 4 mmol/L, will also be included.
Enrolled patients will undergo physiologic assessments using echocardiography, Microscan, Non-invasive cardiac output monitor (NICOM), and extremity temperature device, as well as a blood draw for biomarker assessment.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 18 years old
- determined to have shock physiology, which will be defined by vital sign requirements including SBP < 90 despite appropriate resuscitation (e.g 2 L of normal saline) for at least five minutes.
- Patients that do meet vital sign requirements and vasopressor initiation will also be included
Exclusion Criteria:
- patients determined to have atrial fibrillation with rapid ventricular response or supraventricular tachycardia, and the patient is discharged when the ventricular rate is corrected.
- Patients will also be excluded if found to have to alcohol withdrawal, intoxication, or psychiatric agitation without organic cause.
- Patients with SBP < 90 mm/hg who have been documented to have chronic low blood pressure and their blood pressure is at baseline
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Deterioration
Prazo: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
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Composite in hospital endpoint: 1) acute renal failure (Creatinine 2x baseline or new hemodialysis), non-elective intubation, vasopressor requirement, mortality.
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This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mortality
Prazo: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
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In-hospital mortality.
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This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2013P000004
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