Status:
COMPLETED
PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
BMEYE BV the Netherlands
Edwards Lifesciences
Conditions:
Acute CHF
Acute Stroke Syndromes
Eligibility:
All Genders
18+ years
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 he...
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 pot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT01208077
Start Date
September 1 2010
End Date
September 1 2012
Last Update
August 4 2015
Active Locations (4)
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1
Detroit Receiving Hospital/Wayne State University
Detroit, Michigan, United States, 48201
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
University LaSapienza Rome Sant'Andrea Hospital
Rome, Rome, Italy, 00189
4
VU University Medical Centre
Amsterdam, Amsterdam, Netherlands