Cardiac OutputNCT01103895
Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.
An observational study of Cardiac Output, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiac Output
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.
Who may be able to join
- Patients aged > 21 years
- Patients undergoing surgery involving cardiopulmonary bypass
- Patients instrumented with a thermodilution catheter
Who cannot join
- Patients aged < 21 years
- Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."
- Conditions
- Cardiac Output
- Keywords
- cardiac output, cardiopulmonary bypass, ultrasound dilution
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output after cardiopulmonary bypass
Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass.
Measured: Less than 10 minutes
Secondary outcomes (1)
Cardiac output before cardiopulmonary bypass
Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output.
Measured: Less than 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startJul 2007
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nikolai Krivitski, PhD, DSc, Principal investigator, Transonic Systems Inc.Edward P Nast, MD, Principal investigator, Arnot Ogden Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103895
- Sponsor's protocol ID
- TSI-C-HCE101-4A-H
- Other IDs
- 2R44HL082022-02
- Status last verified
- May 2016
- First submitted
- 13 Apr 2010
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01103895
- Acronym / sponsor ID
- TSI-C-HCE101-4A-H
- Conditions
- Cardiac Output
- Keywords
- cardiac output, cardiopulmonary bypass, ultrasound dilution
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Apr 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.
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.
Key inclusion criteria (3 listed)
- Patients aged > 21 years
- Patients undergoing surgery involving cardiopulmonary bypass
- Patients instrumented with a thermodilution catheter
Key exclusion criteria (2 listed)
- Patients aged < 21 years
- Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)
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
Cardiac output after cardiopulmonary bypass
Time frame: Less than 10 minutes
Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass.
1 secondary outcome
Cardiac output before cardiopulmonary bypass
Time frame: Less than 10 minutes
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Individual participant dataSharing planned: No
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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.
Nikolai Krivitski, PhD, DSc principal investigator
Transonic Systems Inc.
Edward P Nast, MD principal investigator
Arnot Ogden Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, run by Transonic Systems Inc. at 1 site in United States.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 May 2016. 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 United States. 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 was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Cardiac output after cardiopulmonary bypass (time frame: Less than 10 minutes). 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 27 May 2016.