Cardiac OutputNCT01103908
Cardiac Output Measurement at the Conclusion of 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 pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Cardiac Output
- What is being tested?
- HCE101 Cardiopulmonary Support Monitor
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2011
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
Who may be able to join
- Pediatric patients (age < 21 years)
- Pediatric patients undergoing surgery involving cardiopulmonary bypass
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.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Ultrasound Dilution Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.
- Conditions
- Cardiac Output
- Being tested
- HCE101 Cardiopulmonary Support Monitor
- Keywords
- cardiac output, cardiopulmonary bypass, ultrasound dilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCE101 Cardiopulmonary Support MonitorDevice
Measurement of cardiac output using ultrasound dilution technology. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric cardiac output (CO) after CPB | Cardiac output measurements made in pediatric patients after cardiopulmonary bypass. Receives: Device: HCE101 Cardiopulmonary Support Monitor |
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 in pediatric patients after undergoing surgery involving cardiopulmonary bypass
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 startApr 2010
- Primary completionDec 2010
- Study completionAug 2011
Why it stopped: Site PI left position and lack of a suitable replacement PI.
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
- 3 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.Alistair Phillips, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103908
- Sponsor's protocol ID
- TSI-G-HCE101-5A-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 Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01103908
- Acronym / sponsor ID
- TSI-G-HCE101-5A-H
- Conditions
- Cardiac Output
- Keywords
- cardiac output, cardiopulmonary bypass, ultrasound dilution
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Site PI left position and lack of a suitable replacement PI.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (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 pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric cardiac output (CO) after CPB | – | Device: HCE101 Cardiopulmonary Support MonitorCardiac output measurements made in pediatric patients after cardiopulmonary bypass. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
Key inclusion criteria (2 listed)
- Pediatric patients (age < 21 years)
- Pediatric patients undergoing surgery involving cardiopulmonary bypass
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCE101 Cardiopulmonary Support MonitorMeasurement of cardiac output using ultrasound dilution technology. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor. | Device | Pediatric cardiac output (CO) after CPB |
Primary outcome
Cardiac output after cardiopulmonary bypass
Time frame: Less than 10 minutes
Cardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass
Results and safety
The study was stopped early (reason given: Site PI left position and lack of a suitable replacement PI.). 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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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
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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.
Alistair Phillips, MD principal investigator
Nationwide Children's Hospital
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 2 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: Site PI left position and lack of a suitable replacement PI.). 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.