PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation, Hospital, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2010 |
| End Date: | September 2012 |
PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT
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.
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.
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.
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.
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
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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