Cardiac OutputBCMNCT00851422
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
An observational study of Cardiac Output, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Output
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Any pediatric patient (aged < 18 years) who has undergone cardiac transplantation and is already scheduled for a biopsy will be offered the opportunity to participate.
Who may be able to join
- Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts.
Who cannot join
- Patient's age greater than 18 years, and any structural abnormality of the heart.
Trial locations and contacts
1 site in 1 country.
About this study
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.
- Conditions
- Cardiac Output
- Keywords
- Ultrasound Dilution, Cardiac Output, Validation of measured ultrasound dilution cardiac output
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution.
Measured: 5-8 minutes minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 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
- Jeffery J Kim, MD, Principal investigator, Texas Children's Hospital, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851422
- Sponsor's protocol ID
- TSI-C-COSTATUS-5A-H
- Other IDs
- 2R44HL061994-04A2
- Acronym
- BCM
- Status last verified
- May 2012
- First submitted
- 25 Feb 2009
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
PubMed 18496416Crittendon I 3rd, Dreyer WJ, Decker JA, Kim JJ. Ultrasound dilution: an accurate means of determining cardiac output in children. Pediatr Crit Care Med. 2012 Jan;13(1):42-6. doi: 10.1097/PCC.0b013e3182196804.
PubMed 21499176
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
- ClinicalTrials.gov ID
- NCT00851422
- Acronym / sponsor ID
- BCM / TSI-C-COSTATUS-5A-H
- Conditions
- Cardiac Output
- Keywords
- Ultrasound Dilution, Cardiac Output, Validation of measured ultrasound dilution cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 26 Feb 2009 (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.
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any pediatric patient (aged < 18 years) who has undergone cardiac transplantation and is already scheduled for a biopsy will be offered the opportunity to participate.
Key inclusion criteria (1 listed)
- Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts.
Key exclusion criteria (1 listed)
- Patient's age greater than 18 years, and any structural abnormality of the heart.
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
Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution.
Time frame: 5-8 minutes minimum
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 31 May 2012.
- Background: PubMed 18496416Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
- Results publication: PubMed 21499176Crittendon I 3rd, Dreyer WJ, Decker JA, Kim JJ. Ultrasound dilution: an accurate means of determining cardiac output in children. Pediatr Crit Care Med. 2012 Jan;13(1):42-6. doi: 10.1097/PCC.0b013e3182196804.
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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.
Jeffery J Kim, MD principal investigator
Texas Children's Hospital, Baylor College of Medicine
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 1 inclusion and 1 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 31 May 2012. 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 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?
Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution. (time frame: 5-8 minutes minimum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00851422, which also lists 2 linked publications.
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 31 May 2012.