PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient (PREMIUM)
|ClinicalTrials.gov Identifier: NCT01208077|
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : August 4, 2015
|Condition or disease|
|Acute CHF Acute Stroke Syndromes Systemic Infections|
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 Type :||Observational|
|Actual Enrollment :||514 participants|
|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|
Acute Stroke Syndrome
Acute Systemic Infection
- 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.
- 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)
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
|United States, Michigan|
|Detroit Receiving Hospital/Wayne State University|
|Detroit, Michigan, United States, 48201|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|University LaSapienza Rome Sant'Andrea Hospital|
|Rome, Italy, 00189|
|VU University Medical Centre|
|Principal Investigator:||Richard M Nowak, MD||Henry Ford Health System|