Cardiac OutputWSUNCT00851474
Measurement of Cardiac Output and Blood Volumes
An observational study of Cardiac Output, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (older than 18 years of age) in the Intensive Care Unit with arterial and central venous catheters in place.
Who may be able to join
- Adult patients (older than 18 years of age)
- Should have both arterial and central venous catheters already in place
Who cannot join
- Patients who do not have either the arterial or central venous catheters.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.
- Conditions
- Cardiac Output
- Keywords
- COstatus(R), Ultrasound Dilution, Cardiac Output, Blood Volumes, Comparison of COstatus(R) cardiac output with other methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare cardiac output measured by COstatus(R) with other methods such as PA Thermodilution
Measured: 5-8 minutes minimum
Secondary outcomes (1)
Measure blood volumes
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 startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Protocol not renewed
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
- 0 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
- Lawrence Diebel, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851474
- Sponsor's protocol ID
- TSI-C-COSTATUS-7A-H
- Other IDs
- 2R44HL061994-04A2
- Acronym
- WSU
- Status last verified
- May 2016
- First submitted
- 25 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
- Measurement of Cardiac Output and Blood Volumes
- ClinicalTrials.gov ID
- NCT00851474
- Acronym / sponsor ID
- WSU / TSI-C-COSTATUS-7A-H
- Conditions
- Cardiac Output
- Keywords
- COstatus(R), Ultrasound Dilution, Cardiac Output, Blood Volumes, Comparison of COstatus(R) cardiac output with other methods
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol not renewed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2009
- 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.
Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (older than 18 years of age) in the Intensive Care Unit with arterial and central venous catheters in place.
Key inclusion criteria (2 listed)
- Adult patients (older than 18 years of age)
- Should have both arterial and central venous catheters already in place
Key exclusion criteria (1 listed)
- Patients who do not have either the arterial or central venous catheters.
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 cardiac output measured by COstatus(R) with other methods such as PA Thermodilution
Time frame: 5-8 minutes minimum
1 secondary outcome
Measure blood volumes
Time frame: 5-8 minutes minimum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Lawrence Diebel, MD principal investigator
Wayne State University
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 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: withdrawn, 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 withdrawn before enrolling participants, so there are no results.
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 cardiac output measured by COstatus(R) with other methods such as PA 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 NCT00851474, 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.