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