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

3 augusti 2015 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

514

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Potential subjects will be screened and enrolled from the Emergency Department

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hemodynamic Profiles in acute CHF, stroke, and systemic infection
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Henry Ford Health System

Samarbetspartners

Edwards Lifesciences
BMEYE BV the Netherlands

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2010

Primärt slutförande (Faktisk)

1 september 2012

Avslutad studie (Faktisk)

1 september 2012

Studieregistreringsdatum

Först inskickad

14 september 2010

Först inskickad som uppfyllde QC-kriterierna

22 september 2010

Första postat (Uppskatta)

23 september 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2015

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Protocol: HFH DEM 002

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