Trial record 2 of 40 for: PREMIUM

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

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ClinicalTrials.gov Identifier: NCT01208077

Recruitment Status : Completed

First Posted : September 23, 2010

Last Update Posted : August 4, 2015

Sponsor:

Collaborators:

BMEYE BV the Netherlands

Edwards Lifesciences

Information provided by (Responsible Party):

Richard M Nowak, Henry Ford Health System

Study Description

Brief Summary:

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 or disease
Acute CHF Acute Stroke Syndromes Systemic Infections

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.

Study Design


Study Type :	Observational
Actual Enrollment :	514 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT
Study Start Date :	September 2010
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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
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
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

Outcome Measures

Primary Outcome Measures :

Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values) [ Time Frame: 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.

Secondary Outcome Measures :

Hemodynamic Profiles in acute CHF, stroke, and systemic infection [ Time Frame: 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


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
First Posted:	September 23, 2010 Key Record Dates
Last Update Posted:	August 4, 2015
Last Verified:	August 2015

Keywords provided by Richard M Nowak, 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 Sepsis Disease Attributes Pathologic Processes Cerebrovascular Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Infection Systemic Inflammatory Response Syndrome Inflammation

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