Post Cardiac Surgery PatientsNCT00756119
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology
An observational study of Post Cardiac Surgery Patients, run by Transonic Systems Inc. at 1 site in Russia.
Trial summary
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post Cardiac Surgery Patients
- How many people
- 26 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2006to Dec 2009
- 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: Post cardiac surgery adult patients
Who may be able to join
- Post cardiac surgery adult patients
- Patients with heart catheter and arterial catheter
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Research Center of Surgery, Russian Academy of Medical Sciences
Moscow, Moscow, 119992
About this study
Official title: Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to certain patients. The new COstatus system is capable of using the already existing arterial and venous lines placed in critically ill patients and thus provides an opportunity to measure these parameters less invasively and with enough frequency.
The purpose of this study is to measure cardiac output and blood volumes using ultrasound dilution technology (COstatus system)in post cardiac surgery adult patients and compare the cardiac output measurements with a current clinical reference method, thermodilution.
- Conditions
- Post Cardiac Surgery Patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Cardiac Surgery PatientsStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Russian Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Alexsandr A Eremenko, MD, Principal investigator, Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756119
- Sponsor's protocol ID
- TSI-R-COstatus-1A-H
- Status last verified
- May 2012
- First submitted
- 17 Sep 2008
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Eremenko A, Balykov I, Chaus N, Kislukhin V, Krivitski N. Use of an extracorporeal arteriovenous tubing loop to measure cardiac output in intensive care unit patients by ultrasound velocity dilution. ASAIO J. 1998 Sep-Oct;44(5):M462-4. doi: 10.1097/00002480-199809000-00028.
PubMed 9804473Eremenko AA, Chaus NI, Kislukhin VV, Balykov IV. [The determination of cardiac output by the dilution of ultrasonic blood density]. Anesteziol Reanimatol. 1998 Jul-Aug;(4):4-6. Russian.
PubMed 9770808Krivitski 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 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation
- ClinicalTrials.gov ID
- NCT00756119
- Acronym / sponsor ID
- TSI-R-COstatus-1A-H
- Conditions
- Post Cardiac Surgery Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- Russian Academy of Medical Sciences
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Sep 2008 (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.
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to certain patients. The new COstatus system is capable of using the already existing arterial and venous lines placed in critically ill patients and thus provides an opportunity to measure these parameters less invasively and with enough frequency.
The purpose of this study is to measure cardiac output and blood volumes using ultrasound dilution technology (COstatus system)in post cardiac surgery adult patients and compare the cardiac output measurements with a current clinical reference method, thermodilution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post cardiac surgery adult patients
Key inclusion criteria (2 listed)
- Post cardiac surgery adult patients
- Patients with heart catheter and arterial catheter
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 9804473Eremenko A, Balykov I, Chaus N, Kislukhin V, Krivitski N. Use of an extracorporeal arteriovenous tubing loop to measure cardiac output in intensive care unit patients by ultrasound velocity dilution. ASAIO J. 1998 Sep-Oct;44(5):M462-4. doi: 10.1097/00002480-199809000-00028.
- Background: PubMed 9770808Eremenko AA, Chaus NI, Kislukhin VV, Balykov IV. [The determination of cardiac output by the dilution of ultrasonic blood density]. Anesteziol Reanimatol. 1998 Jul-Aug;(4):4-6. Russian.
- 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.
Alexsandr A Eremenko, MD principal investigator
Russian Academy of Medical Sciences
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 Post Cardiac Surgery Patients, run by Transonic Systems Inc. at 1 site in Russia.
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 0 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 Russia. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00756119, which also lists 3 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.