PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Acute CHF Acute Stroke Syndromes Systemic Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT |
- Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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)
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
Acute CHF
|
Acute Stroke Syndrome
|
Acute Systemic Infection
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Potential subjects will be screened and enrolled from the Emergency Department
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
Contacts and Locations| Contact: Richard M Nowak, MD | 313 916-1909 | rnowak1@hfhs.org |
| Contact: Michele L Moyer, BSN | 313 916-3678 | mmoyer1@hfhs.org |
| United States, Michigan | |
| Detroit Receiving Hospital/Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Phil Levy, MD, MPH 313-993-8558 plevy@med.wayne.edu | |
| Contact: Lynnmarie Mango, MPH 313 745-4350 lmmango@med.wayne.edu | |
| Principal Investigator: Phillip D Levy, MD | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Michele L Moyer, RN BSN 313-916-3678 mmoyer1@hfhs.org | |
| Contact: Rebecca Huyghe, CRA 313 916-4822 rhuyghe1@hfhs.org | |
| Principal Investigator: Richard M Nowak, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Rakesh Engineer, MD 216-445-4590 enginer@ccf.org | |
| Contact: Tertius Tuy 216 444-5424 tuyt2@ccf.org | |
| Principal Investigator: Rakesh Engineer, MD | |
| Italy | |
| University LaSapienza Rome Sant'Andrea Hospital | Recruiting |
| Rome, Italy, 00189 | |
| Contact: Salvatore DiSomma, MD 39 06 3377-5592 salvatore.disomma@uniroma.it | |
| Contact: Serena Gramaccini 39 06 3377-5581 serenagramaccini@libero.it | |
| Principal Investigator: Salvatore DiSomma, MD | |
| Netherlands | |
| VU University Medical Centre | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Prabath Nanayakkara, MD 011 3 120 444-4444 ext 6791 p.nanayakkara@vumc.nl | |
| Contact: Suzanne Hochheimer, MD 011 3 120 444-0636 s.hochheimer@vumc.nl | |
| Principal Investigator: Prabath Nanayakkara, MD | |
| Sub-Investigator: Suzanne Hochheimer, MD | |
| Principal Investigator: | Richard M Nowak, MD | Henry Ford Health System |
More Information
No publications provided
| Responsible Party: | Dr. Richard M. Nowak, MD, Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT01208077 History of Changes |
| Other Study ID Numbers: | Protocol: HFH DEM 002 |
| Study First Received: | September 14, 2010 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board Italy: Ethics Committee Italy: Ministry of Health Netherlands: Independent Ethics Committee |
Keywords provided by 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 Cerebral Infarction Sepsis Disease Attributes Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Infection Systemic Inflammatory Response Syndrome Inflammation |
ClinicalTrials.gov processed this record on May 16, 2013