Cardiac Output, HighNCT00583687
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
A study testing Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor), Passive leg raising and Volume challenge / Change of vasoactive drugs or inotropics in people with Cardiac Output, High and Cardiac Output, Low, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or… 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, Vasodilation
- What is being tested?
- Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor), Passive leg raising and Volume challenge / Change of vasoactive drugs or inotropics
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2007to Jan 2009
- Phase
- Interventional
- 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
Who may be able to join
- Indication for invasive hemodynamic monitoring with pulmonary artery catheter and arterial catheter
- Hemodynamic instability (need for vasoactive drugs, inotropics or volume).
Who cannot join
- Age < 18.
- Patient with contraindications for the placement of arterial cannula.
- Patient with history or clinical findings of aortic valve regurgitation.
- Atrial fibrillation.
- Patient being treated with an intra-aortic balloon pump.
- Limitation of therapy due to bad prognosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intensive Care Medicine, University Hospital Inselspital, Berne
Bern, 3010
About this study
The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously, global parameters of oxygen delivery and consumption will be compared with regional flow parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While continuous thermodilution cardiac output is used for patient management, pulse contour cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used for monitoring.
- Being tested
- Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor), Passive leg raising, Volume challenge / Change of vasoactive drugs or inotropics, Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)
- Keywords
- Arterial pulse contour cardiac output, Changing vascular tone, Tissue Oxymetry, Prediction of Fluid Responsiveness
- Medical subject headings
- Cardiac Output, High, Cardiac Output, Low, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)Device
Also called Vigileo TM / Flotrac TM
Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.
Passive leg raisingOther
Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.
Volume challenge / Change of vasoactive drugs or inotropicsOther
Either a volume challenge (using colloids or crystalloids) or a change in the dosage of of vasoactive drugs or inotropics, or a combination of them, as proposed by the treating physician.
Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)Device
Also called Inspectra TM, O-To-See TM
Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cardiac output measured by three different techniques during changes of vascular tone
Measured: 2 hours
Secondary outcomes (2)
Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.
Measured: 2 hours
Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, HighStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Investigators
- Christoph C Ganter, M.D., Principal investigator, Department of Intensive Care Medicine, University Hospital, Inselspital, Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583687
- Sponsor's protocol ID
- KEK-3107-UHB-1316
- Status last verified
- Apr 2009
- First submitted
- 18 Dec 2007
- Last updated
- 28 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
- ClinicalTrials.gov ID
- NCT00583687
- Acronym / sponsor ID
- KEK-3107-UHB-1316
- Keywords
- Arterial pulse contour cardiac output, Changing vascular tone, Tissue Oxymetry, Prediction of Fluid Responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 31 Dec 2007 (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 compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously, global parameters of oxygen delivery and consumption will be compared with regional flow parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While continuous thermodilution cardiac output is used for patient management, pulse contour cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used for monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for invasive hemodynamic monitoring with pulmonary artery catheter and arterial catheter
- Hemodynamic instability (need for vasoactive drugs, inotropics or volume).
Key exclusion criteria (6 listed)
- Age < 18.
- Patient with contraindications for the placement of arterial cannula.
- Patient with history or clinical findings of aortic valve regurgitation.
- Atrial fibrillation.
- Patient 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 |
|---|---|---|
| Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)Also: Vigileo TM / Flotrac TMAttachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient. | Device | – |
| Passive leg raisingPassive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis. | Other | – |
| Volume challenge / Change of vasoactive drugs or inotropicsEither a volume challenge (using colloids or crystalloids) or a change in the dosage of of vasoactive drugs or inotropics, or a combination of them, as proposed by the treating physician. | Other | – |
| Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)Also: Inspectra TM, O-To-See TMTissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period. | Device | – |
Primary outcome
Changes of cardiac output measured by three different techniques during changes of vascular tone
Time frame: 2 hours
2 secondary outcomes
Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.
Time frame: 2 hours
Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.
Time frame: 2 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 28 Apr 2009.
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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.
Christoph C Ganter, M.D. principal investigator
Department of Intensive Care Medicine, University Hospital, Inselspital, Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor), Passive leg raising and Volume challenge / Change of vasoactive drugs or inotropics in people with Cardiac Output, High and Cardiac Output, Low, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 inclusion and 6 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 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does the primary outcome measure?
Changes of cardiac output measured by three different techniques during changes of vascular tone (time frame: 2 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 28 Apr 2009.