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PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient (PREMIUM)

3 août 2015 mis à jour par: Richard M Nowak, Henry Ford Health System

PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT

This multinational registry (3 USA, 2 European centers) will capture in the ED continuous non invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients presenting with acute heart failure, stroke syndromes and systemic infection. Patients will be observed after their Emergency Department (ED) disposition to determine clinical outcomes (length of stay in the hospital, the development of any organ dysfunction, mortality and need for unscheduled medical care within the ensuing 30 days). It is anticipated that specific ED hemodynamic profiles will be predictive of better clinical outcomes than others. This information will provide the outcome data needed to design future therapeutic trials that will evaluate the effect of ED hemodynamic manipulations on overall patient management and outcomes.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

514

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Italie
      • Rome, Italie, 00189
        • University LaSapienza Rome Sant'Andrea Hospital
  • Pays-Bas
      • Amsterdam, Pays-Bas
        • VU University Medical Centre
  • États-Unis
    • Michigan
      • Detroit, Michigan, États-Unis, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, États-Unis, 48201
        • Detroit Receiving Hospital/Wayne State University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Potential subjects will be screened and enrolled from the Emergency Department

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Acute CHF
  1. Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint
  2. Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF
  3. Known history of physician diagnosed CHF
  4. 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
Acute Stroke Syndrome
  1. Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint
  2. Initial treating ED physician impression that the abnormal neurological symptoms/signs are most likely caused by an acute stroke syndrome
  3. Non contrast head CT will be ordered by the treating physician as part of the patient's work up
Acute Systemic Infection
  1. 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
  2. Blood cultures and/or a blood lactate will be ordered by the treating physician as part of the patient's work up

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values)
Délai: 4 hours
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.
4 hours

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Hemodynamic Profiles in acute CHF, stroke, and systemic infection
Délai: 4 Hours

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Henry Ford Health System

Collaborateurs

Edwards Lifesciences
BMEYE BV the Netherlands

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2010

Achèvement primaire (Réel)

1 septembre 2012

Achèvement de l'étude (Réel)

1 septembre 2012

Dates d'inscription aux études

Première soumission

14 septembre 2010

Première soumission répondant aux critères de contrôle qualité

22 septembre 2010

Première publication (Estimation)

23 septembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 août 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2015

Dernière vérification

1 août 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Protocol: HFH DEM 002

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