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

Systemic Infections Clinical Trial

— PREMIUM  

Official title:

PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208077
• Other study ID #: Protocol: HFH DEM 002
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: August 3, 2015
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2015
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardItaly: Ethics CommitteeItaly: Ministry of HealthNetherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute CHF
• Acute Stroke Syndromes
• Sepsis
• Stroke
• Systemic Infections

Locations

Country	Name	City	State
Italy	University LaSapienza Rome Sant'Andrea Hospital	Rome
Netherlands	VU University Medical Centre	Amsterdam
United States	Detroit Receiving Hospital/Wayne State University	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Henry Ford Health System	BMEYE BV the Netherlands, Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hemodynamic Profiles in acute CHF, stroke, and systemic infection	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	No