Acute CHFPREMIUMNCT01208077
PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient
An observational study of Acute CHF and Acute Stroke Syndromes, run by Henry Ford Health System at 4 sites in 3 countries.
Trial 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 heart failure, stroke syndromes and systemic infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute CHF, Acute Stroke Syndromes, Systemic Infections
- How many people
- 514 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential subjects will be screened and enrolled from the Emergency Department
Who may be able to join
- 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
- Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint
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- 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
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Detroit Receiving Hospital/Wayne State University
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute CHF, Acute Stroke Syndromes, Systemic Infections
- Keywords
- ED hemodynamic profiles, patients treated under current clinical standards, Acute CHF, Stroke syndromes, Systemic infection
- Medical subject headings
- Toxemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute CHF | 1. Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint 2. Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF 3. Known history of physician diagnosed CHF 4. 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 | |
| Acute Stroke Syndrome | 1. Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint 2. Initial treating ED physician impression that the abnormal neurological symptoms/signs are most likely caused by an acute stroke syndrome 3. Non contrast head CT will be ordered by the treating physician as part of the patient's work up | |
| Acute Systemic Infection | 1. 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 2. Blood cultures and/or a blood lactate will be ordered by the treating physician as part of the patient's work up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values)
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.
Measured: 4 hours
Secondary outcomes (1)
Hemodynamic Profiles in acute CHF, stroke, and systemic infection
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)
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CHFStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- BMEYE BV the Netherlands, Edwards Lifesciences
- Responsible party
- Principal investigator, Richard M Nowak, Henry Ford Health System
- Investigators
- Richard M Nowak, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208077
- Sponsor's protocol ID
- Protocol: HFH DEM 002
- Acronym
- PREMIUM
- Status last verified
- Aug 2015
- First submitted
- 14 Sep 2010
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT
- ClinicalTrials.gov ID
- NCT01208077
- Acronym / sponsor ID
- PREMIUM / Protocol: HFH DEM 002
- Conditions
- Acute CHF, Acute Stroke Syndromes, Systemic Infections
- Keywords
- ED hemodynamic profiles, patients treated under current clinical standards, Acute CHF, Stroke syndromes, Systemic infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- BMEYE BV the Netherlands, Edwards Lifesciences
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute CHF | – | –1. Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint 2. Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF 3. Known history of physician diagnosed CHF 4. 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 |
| Acute Stroke Syndrome | – | –1. Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint 2. Initial treating ED physician impression that the abnormal neurological symptoms/signs are most likely caused by an acute stroke syndrome 3. Non contrast head CT will be ordered by the treating physician as part of the patient's work up |
| Acute Systemic Infection | – | –1. 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 2. Blood cultures and/or a blood lactate will be ordered by the treating physician as part of the patient's work up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be screened and enrolled from the Emergency Department
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Hemodynamic Profiles in acute CHF, stroke, and systemic infection
Time frame: 4 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M Nowak, MD principal investigator
Henry Ford Health System
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute CHF and Acute Stroke Syndromes, run by Henry Ford Health System at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.