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

This study has been completed.
Sponsor:
Collaborators:
BMEYE BV the Netherlands
Edwards Lifesciences
Information provided by (Responsible Party):
Richard M Nowak, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01208077
First received: September 14, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition
Acute CHF
Acute Stroke Syndromes
Systemic Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Hemodynamic Profiles in acute CHF, stroke, and systemic infection [ Time Frame: 4 Hours ] [ Designated as safety issue: No ]

    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)



Enrollment: 514
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Potential subjects will be screened and enrolled from the Emergency Department

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208077

Locations
United States, Michigan
Detroit Receiving Hospital/Wayne State University
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Italy
University LaSapienza Rome Sant'Andrea Hospital
Rome, Italy, 00189
Netherlands
VU University Medical Centre
Amsterdam, Netherlands
Sponsors and Collaborators
Henry Ford Health System
BMEYE BV the Netherlands
Edwards Lifesciences
Investigators
Principal Investigator: Richard M Nowak, MD Henry Ford Health System
  More Information

No publications provided

Responsible Party: Richard M Nowak, Sr, Staff Emergency Medicine, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01208077     History of Changes
Other Study ID Numbers: Protocol: HFH DEM 002
Study First Received: September 14, 2010
Last Updated: June 11, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
Italy: Ethics Committee
Italy: Ministry of Health
Netherlands: Independent Ethics Committee

Keywords provided by Henry Ford Health System:
ED hemodynamic profiles
patients treated under current clinical standards
Acute CHF
Stroke syndromes
Systemic infection

Additional relevant MeSH terms:
Emergencies
Stroke
Cerebral Infarction
Sepsis
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 01, 2014