Post Cardiac SurgeryNCT01662141
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
An observational study of Post Cardiac Surgery, run by Transonic Systems Inc. at 1 site in Sweden.
Trial summary
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Post Cardiac Surgery
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2010to Sep 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: Pediatric Patients (< 15) in the ICU
Who may be able to join
- Children <15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.
Who cannot join
- Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
- Children with persistent severe arrhythmias.
- Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.
Read the detailed description
The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.
COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.
- Conditions
- Post Cardiac Surgery
- Keywords
- Cardiac output, Perivascular Probe
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.
To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children < 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.
Measured: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 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 Post Cardiac SurgeryStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Lindberg, MD, PhD, Principal investigator, University Hospital in Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662141
- Sponsor's protocol ID
- TSI-S-COstatus-13A-H
- Other IDs
- IRB
- Status last verified
- Aug 2012
- First submitted
- 6 Aug 2012
- Last updated
- 10 Aug 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 18496416
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01662141
- Acronym / sponsor ID
- TSI-S-COstatus-13A-H
- Conditions
- Post Cardiac Surgery
- Keywords
- Cardiac output, Perivascular Probe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Aug 2012 (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 measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.
Detailed description
The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.
COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Patients (< 15) in the ICU
Key inclusion criteria (1 listed)
- Children <15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.
Key exclusion criteria (3 listed)
- Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
- Children with persistent severe arrhythmias.
- Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.
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
Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.
Time frame: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.
To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children < 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.
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 10 Aug 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.
Related trials for Post Cardiac Surgery
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
RecruitingObservational study
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction
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.
Lars Lindberg, MD, PhD principal investigator
University Hospital in Lund
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, run by Transonic Systems Inc. at 1 site in Sweden.
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 3 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 10 Aug 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 Sweden. 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?
Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery. (time frame: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.). 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 NCT01662141, 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 10 Aug 2012.