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

3. august 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

514

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Detroit Receiving Hospital/Wayne State University
  • Holland
      • Amsterdam, Holland
        • VU University Medical Centre
  • Italien
      • Rome, Italien, 00189
        • University LaSapienza Rome Sant'Andrea Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Henry Ford Health System

Samarbejdspartnere

Edwards Lifesciences
BMEYE BV the Netherlands

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2010

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

14. september 2010

Først indsendt, der opfyldte QC-kriterier

22. september 2010

Først opslået (Skøn)

23. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Protocol: HFH DEM 002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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