PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient (PREMIUM)
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ClinicalTrials.gov Identifier: NCT01208077 |
Recruitment Status
:
Completed
First Posted
: September 23, 2010
Last Update Posted
: August 4, 2015
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Condition or disease |
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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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |

Group/Cohort |
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Acute CHF
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Acute Stroke Syndrome
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Acute Systemic Infection
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- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

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 | |
Italy | |
University LaSapienza Rome Sant'Andrea Hospital | |
Rome, Italy, 00189 | |
Netherlands | |
VU University Medical Centre | |
Amsterdam, Netherlands |
Principal Investigator: | Richard M Nowak, MD | Henry Ford Health System |
Responsible Party: | Richard M Nowak, Sr, Staff Emergency Medicine, Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT01208077 History of Changes |
Other Study ID Numbers: |
Protocol: HFH DEM 002 |
First Posted: | September 23, 2010 Key Record Dates |
Last Update Posted: | August 4, 2015 |
Last Verified: | August 2015 |
Keywords provided by Richard M Nowak, Henry Ford Health System:
ED hemodynamic profiles patients treated under current clinical standards Acute CHF Stroke syndromes Systemic infection |
Additional relevant MeSH terms:
Emergencies Stroke Sepsis Disease Attributes Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Infection Systemic Inflammatory Response Syndrome Inflammation |