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

3. august 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

514

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forente stater, 48201
        • Detroit Receiving Hospital/Wayne State University
  • Italia
      • Rome, Italia, 00189
        • University LaSapienza Rome Sant'Andrea Hospital
  • Nederland
      • Amsterdam, Nederland
        • VU University Medical Centre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Potential subjects will be screened and enrolled from the Emergency Department

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hemodynamic Profiles in acute CHF, stroke, and systemic infection
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Henry Ford Health System

Samarbeidspartnere

Edwards Lifesciences
BMEYE BV the Netherlands

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2010

Primær fullføring (Faktiske)

1. september 2012

Studiet fullført (Faktiske)

1. september 2012

Datoer for studieregistrering

Først innsendt

14. september 2010

Først innsendt som oppfylte QC-kriteriene

22. september 2010

Først lagt ut (Anslag)

23. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2015

Sist bekreftet

1. august 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Protocol: HFH DEM 002

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