PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient (PREMIUM)
PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT
Visão geral do estudo
Status
Descrição detalhada
The PREMIUM Registry is a multinational, prospective, observational convenience study of the ED hemodynamic profiles of patients presenting with acute CHF, stroke and systemic infections and their potential relationship with patient outcomes. Continuous hemodynamics will be measured by noninvasive means using the Nexfin device and outcomes (in hospital length of stay, the interval development of organ dysfunction and mortality or the need for unscheduled medical care within the ensuing 30 days) will be captured within the registry.
The treating ED physicians will be blinded to the hemodynamic monitoring and there will be no modification of the standard care that each patient receives. Hospital charts will be reviewed and patients/family members will be additionally called at 30 days after the hospital visit in order to collect any additional outcome data.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Detroit, Michigan, Estados Unidos, 48201
- Detroit Receiving Hospital/Wayne State University
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Amsterdam, Holanda
- VU University Medical Centre
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Rome, Itália, 00189
- University LaSapienza Rome Sant'Andrea Hospital
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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:
General Inclusion Criteria
- 18 years of age or older
- Able to provide informed consent
- No initiated therapy since arrival to the ED
- Must be enrolled within 4 hours of arrival to the ED
Inclusion Criteria for Acute CHF
- Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint
- Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF
- Known history of physician diagnosed CHF
- Natriuretic peptide (BNP, MR-pro ANP, NT pro BNP) level will be ordered by the treating physician as part of the patient's work up
Inclusion Criteria for Acute Stroke Syndrome
- Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint
- Initial treating ED physician impression that the abnormal neurological symptoms/signs are most likely caused by an acute stroke syndrome
- Non contrast head CT will be ordered by the treating physician as part of the patient's work up
Inclusion Criteria for Acute Systemic Infection
- Any combinations of acute (within 3 days) symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
- Blood cultures and/or a blood lactate will be ordered by the treating physician as part of the patient's work up
Exclusion Criteria:
General Exclusion Criteria
- ESRD requiring hemo or peritoneal dialysis
- Suspected pregnancy
- Not able to be followed up in 30 days
- Patients with "comfort only" DNR status
- Patients with known STEMI
- Excessive agitation
- Transferred from another treating facility
- Known aortic valve disease
- On continuous IV home infusions (such as milrinone, primacor)
- Known Left Ventricular Assist device (LVAD)
- Known prior enrollment in this study
- In current therapeutic Investigational study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Acute CHF
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Acute Stroke Syndrome
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Acute Systemic Infection
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values)
Prazo: 4 hours
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Describe the 4 hour continuous ED hemodynamic profiles (CO, SVR, SV, DP/DT and Indexed values)of patients treated under current clinical standards with acute CHF, stroke syndromes and systemic infection.
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4 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Hemodynamic Profiles in acute CHF, stroke, and systemic infection
Prazo: 4 Hours
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Describe the hemodynamic profiles within existing risk stratification groupings currently used for these 3 disease states. These include but are not limited to BNP and troponin values for acute CHF, infarct/bleed size in acute stroke syndromes, and WBC and procalcitonin (where applicable) and blood lactate levels in systemic infections. Determine which hemodynamic profiles measured in the ED predict clinical outcomes (mortality, end organ dysfunction, and length of stay) |
4 Hours
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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 (Estimativa)
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
- Protocol: HFH DEM 002
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