Cardiac Output, HighNCT00354211
Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable
An observational study of Cardiac Output, High and Cardiac Output, Low, run by Edwards Lifesciences at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic instability, in comparison to standard of care will shorten the time needed to stabilize the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, High, Cardiac Output, Low
- What is being tested?
- minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)
- Type of treatment
- Medical device
- How many people
- 392 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2006to Dec 2007
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients emergently admitted to the Intensive Care Unit who develop hemodynamic instability within 6 hours of admission.
Who may be able to join
- Patient newly admitted to the ICU due to an emergency unplanned admission.
- Patient diagnosed with hemodynamic instability at or becomes unstable within 6 hours of ICU admission.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patient is included in the study according to the specific regulations of the participating center: this may include a deferred consent, consent by designee, consent by independent physician or a combination thereof.
- Patient must be 18 years old or older.
Who cannot join
- Patients with contraindications for the placement of radial, femoral, dorsalis pedis, or other arterial cannula.
- Patients with a pulmonary artery catheter.
- Patients who are hemodynamically stable.
- Patients with history or clinical findings of aortic valve regurgitation.
- Patients being treated with an intra-aortic balloon pump.
- Female patient is pregnant.
- Patient is currently participating in an investigational drug or another device study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
Kuopio University Hospital
Kuopio, 70211
Tampere Unversity Hospital
Tampere, 33521
About this study
Official title: TREASURE: Treatment With Minimally-Invasive Cardiac Output for Assessment of User Derived Results Evaluating Economic Benefit
The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic instability, in comparison to standard of care will shorten the time needed to stabilize the patient.
The researchers hypothesize that early detection of instability improves the prognosis and treatment outcome of emergency intensive care patients with hemodynamic instability.
Read the detailed description
Hemodynamic instability during the first 24-hours of Intensive Care Unit (ICU) admission is associated with increased risk of subsequent morbidity and mortality. Goal-directed hemodynamic support has been successfully used in a variety of patients to improve outcome. In contrast, a similar therapeutic approach applied later, or in patients with established multi-organ failure, has no beneficial effect and may even worsen the outcome.
It is conceivable that there is a window of opportunity during the phases of hemodynamic instability where therapeutic interventions have the greatest potential to influence the subsequent course of critical illness. Large scale uses of therapeutic protocols for early intervention have been hampered by logistic problems. The burden of installing invasive hemodynamic monitoring and protocols is labor intensive and requires a continuous presence of personnel with a thorough understanding of complex physiology. Various techniques have been introduced for monitoring cardiac output, stroke volume, or their surrogates. The disadvantage of these technologies so far have included user dependence of measurements results, need for calibration, and limitations in applicability. Edwards Lifesciences has developed a new algorithm for the determination of cardiac output using arterial pressure data. The FloTrac™ system, which includes the FloTrac™ sensor and Vigileo™ monitor, is utilized to capture the arterial pressure-based cardiac output measurement, which will be hereinafter referred to as APCO (Arterial Pressure Cardiac Output). This system uses an existing arterial catheter (placed in the femoral or radial artery) and does not require calibration by an external reference method. We hypothesize that using the FloTrac™ system to continuously monitor cardiac output, in addition to traditional vital signs, cardiovascular instability will be identified earlier and result in earlier intervention. In addition, following earlier diagnosis, more precise intervention will be available. If this can be achieved, patients will likely show better outcomes by reduced length of hospital stay, ICU time, Mechanical Ventilation time, incidence of renal compromise, and other related morbidity/mortality and need less ICUresources.
- Conditions
- Cardiac Output, High, Cardiac Output, Low
- Being tested
- minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)
- Keywords
- Cardiac Output, Hemodynamic Phenomena
- Medical subject headings
- Cardiac Output, High, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | FLOTRAC™ SYSTEM Receives: Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) | |
| 2 | Control Group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, HighStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jukka Takala, M.D., Ph.D., Principal investigator, University Hospital Bern (Inselspital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354211
- Sponsor's protocol ID
- Study # 2005-06, Revision B
- Status last verified
- Feb 2013
- First submitted
- 18 Jul 2006
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Takala J, Ruokonen E, Tenhunen JJ, Parviainen I, Jakob SM. Early non-invasive cardiac output monitoring in hemodynamically unstable intensive care patients: a multi-center randomized controlled trial. Crit Care. 2011 Jun 15;15(3):R148. doi: 10.1186/cc10273.
PubMed 21676229
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREASURE: Treatment With Minimally-Invasive Cardiac Output for Assessment of User Derived Results Evaluating Economic Benefit
- ClinicalTrials.gov ID
- NCT00354211
- Acronym / sponsor ID
- Study # 2005-06, Revision B
- Conditions
- Cardiac Output, High, Cardiac Output, Low
- Keywords
- Cardiac Output, Hemodynamic Phenomena
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Jul 2006 (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.
The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic instability, in comparison to standard of care will shorten the time needed to stabilize the patient.
The researchers hypothesize that early detection of instability improves the prognosis and treatment outcome of emergency intensive care patients with hemodynamic instability.
Detailed description
Hemodynamic instability during the first 24-hours of Intensive Care Unit (ICU) admission is associated with increased risk of subsequent morbidity and mortality. Goal-directed hemodynamic support has been successfully used in a variety of patients to improve outcome. In contrast, a similar therapeutic approach applied later, or in patients with established multi-organ failure, has no beneficial effect and may even worsen the outcome.
It is conceivable that there is a window of opportunity during the phases of hemodynamic instability where therapeutic interventions have the greatest potential to influence the subsequent course of critical illness. Large scale uses of therapeutic protocols for early intervention have been hampered by logistic problems. The burden of installing invasive hemodynamic monitoring and protocols is labor intensive and requires a continuous presence of personnel with a thorough understanding of complex physiology. Various techniques have been introduced for monitoring cardiac output, stroke volume, or their surrogates. The disadvantage of these technologies so far have included user dependence of measurements results, need for calibration, and limitations in applicability. Edwards Lifesciences has developed a new algorithm for the determination of cardiac output using arterial pressure data. The FloTrac™ system, which includes the FloTrac™ sensor and Vigileo™ monitor, is utilized to capture the arterial pressure-based cardiac output measurement, which will be hereinafter referred to as APCO (Arterial Pressure Cardiac Output). This system uses an existing arterial catheter (placed in the femoral or radial artery) and does not require calibration by an external reference method. We hypothesize that using the FloTrac™ system to continuously monitor cardiac output, in addition to traditional vital signs, cardiovascular instability will be identified earlier and result in earlier intervention. In addition, following earlier diagnosis, more precise intervention will be available. If this can be achieved, patients will likely show better outcomes by reduced length of hospital stay, ICU time, Mechanical Ventilation time, incidence of renal compromise, and other related morbidity/mortality and need less ICUresources.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)FLOTRAC™ SYSTEM |
| 2 | – | –Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients emergently admitted to the Intensive Care Unit who develop hemodynamic instability within 6 hours of admission.
Key inclusion criteria (5 listed)
- Patient newly admitted to the ICU due to an emergency unplanned admission.
- Patient diagnosed with hemodynamic instability at or becomes unstable within 6 hours of ICU admission.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patient is included in the study according to the specific regulations of the participating center: this may include a deferred consent, consent by designee, consent by independent physician or a combination thereof.
- Patient must be 18 years old or older.
Key exclusion criteria (7 listed)
- Patients with contraindications for the placement of radial, femoral, dorsalis pedis, or other arterial cannula.
- Patients with a pulmonary artery catheter.
- Patients who are hemodynamically stable.
- Patients with history or clinical findings of aortic valve regurgitation.
- Patients being treated with an intra-aortic balloon pump.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) | Device | 1 |
Primary outcome
Not reported in the source record.
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 11 Feb 2013.
- Results publication: PubMed 21676229Takala J, Ruokonen E, Tenhunen JJ, Parviainen I, Jakob SM. Early non-invasive cardiac output monitoring in hemodynamically unstable intensive care patients: a multi-center randomized controlled trial. Crit Care. 2011 Jun 15;15(3):R148. doi: 10.1186/cc10273.
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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.
Jukka Takala, M.D., Ph.D. principal investigator
University Hospital Bern (Inselspital)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, High and Cardiac Output, Low, run by Edwards Lifesciences at 3 sites in 2 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 5 inclusion and 7 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, Switzerland. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00354211, which also lists 1 linked publication.
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 11 Feb 2013.