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

NCT ID: NCT01208077

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 514 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-09-30

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.

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.

Conditions

Acute CHF; Acute Stroke Syndromes; Systemic Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BMEYE BV the Netherlands

UNKNOWN

Sponsor Role: collaborator

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Richard M Nowak

Sr, Staff Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard M Nowak, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Detroit Receiving Hospital/Wayne State University

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

University LaSapienza Rome Sant'Andrea Hospital

Rome, Rome, Italy

VU University Medical Centre

Amsterdam, Amsterdam, Netherlands

Countries

United States; Italy; Netherlands

Other Identifiers

Protocol: HFH DEM 002

Identifier Type: -

Identifier Source: org_study_id