Cardiac SurgeryNCT01567371
LiDCO Monitor Study
A study testing LiDCO rapid monitor in people with Cardiac Surgery, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- LiDCO rapid monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood
This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.
- Conditions
- Cardiac Surgery
- Being tested
- LiDCO rapid monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiDCO rapid monitorDevice
Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.
| Study group | Role | What they receive |
|---|---|---|
| LiDCO rapid monitor | Experimental | Not described Receives: Device: LiDCO rapid monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pulse Pressure Variability From Baseline to Post-ANH
The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
Measured: 1 Day
Secondary outcomes (1)
Difference in Stroke Volume Variability From Baseline to Post ANH.
The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567371
- Sponsor's protocol ID
- IRB12-00096
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2012
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood
- ClinicalTrials.gov ID
- NCT01567371
- Acronym / sponsor ID
- IRB12-00096
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 15 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LiDCO rapid monitor | Experimental | Device: LiDCO rapid monitor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiDCO rapid monitorTechnology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability. | Device | LiDCO rapid monitor |
Primary outcome
Difference in Pulse Pressure Variability From Baseline to Post-ANH
Time frame: 1 Day
The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
1 secondary outcome
Difference in Stroke Volume Variability From Baseline to Post ANH.
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cardiac Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiDCO rapid monitor in people with Cardiac Surgery, run by Nationwide Children's Hospital 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 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 15 Apr 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?
Yes. Results are posted in the registry (first posted 15 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Pulse Pressure Variability From Baseline to Post-ANH (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2016.