Cardiac OutputGCHNCT00853437
Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
An observational study of Cardiac Output, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Cardiac Output
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.
Who may be able to join
- Patients with in situ central venous and arterial catheters
- Ability to draw blood from arterial and central venous catheters
- Presence of parent or guardian to provide consent
Who cannot join
- Patients over 16 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Golisano Children's Hospital
Rochester, New York, 14642
About this study
The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.
- Conditions
- Cardiac Output
- Keywords
- Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference.
Measured: 5-8 minutes minimum
Secondary outcomes (1)
Measure blood volumes to compare effects of volume infusion and furosemide.
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 posted2 Mar 2009 (estimated)
- Study startJan 2009
- 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 (1)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
- 7 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
- Karen Powers, MD, Principal investigator, Golisano Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853437
- Sponsor's protocol ID
- TSI-G-COSTATUS-2A-H
- Other IDs
- 2R44HL061994-04A2
- Acronym
- GCH
- Status last verified
- May 2016
- First submitted
- 27 Feb 2009
- Last updated
- 27 May 2016
- 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 18496416
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
- Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
- ClinicalTrials.gov ID
- NCT00853437
- Acronym / sponsor ID
- GCH / TSI-G-COSTATUS-2A-H
- Conditions
- Cardiac Output
- Keywords
- Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Mar 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.
The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.
Key inclusion criteria (3 listed)
- Patients with in situ central venous and arterial catheters
- Ability to draw blood from arterial and central venous catheters
- Presence of parent or guardian to provide consent
Key exclusion criteria (1 listed)
- Patients over 16 years of age.
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
Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference.
Time frame: 5-8 minutes minimum
1 secondary outcome
Measure blood volumes to compare effects of volume infusion and furosemide.
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 27 May 2016.
- 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.
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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.
Karen Powers, MD principal investigator
Golisano 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 3 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 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 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?
Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference. (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 NCT00853437, 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 27 May 2016.