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

NCT01208077 | Completed

• 1 other identifier: Protocol: HFH DEM 002
• Study Type: observational
• Target: 514
• Locations: 3 countries
• Sites: 4

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.

Conditions

Acute CHF; Acute Stroke Syndromes; Systemic Infections

Keywords

ED hemodynamic profiles; patients treated under current clinical standards; Acute CHF; Stroke syndromes; Systemic infection

Outcome Measures

Primary Outcomes (1)

• Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values)

  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

Secondary Outcomes (1)

• Hemodynamic Profiles in acute CHF, stroke, and systemic infection

  4 Hours

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential subjects will be screened and enrolled from the Emergency Department

You may qualify if:

• 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
• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• BMEYE BV the Netherlands: collaborator
• Edwards Lifesciences: collaborator

Study Sites (4)

Detroit Receiving Hospital/Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University LaSapienza Rome Sant'Andrea Hospital

Rome, Rome, 00189, Italy

Location

VU University Medical Centre

Amsterdam, Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Toxemia; Stroke

Condition Hierarchy (Ancestors)

Infections; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard M Nowak, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr, Staff Emergency Medicine

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 23, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

IT (1); NL (1); US (2)