Cardiac SurgeryNCT03139929
Measurement of MSFP and Stressed Volume With CardioQ+®
An observational study of Cardiac Surgery and CABG, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
To study the reliablity of MSFP and stressed volume to follow volume loading and to predict fload loading responsiveness in patients after elective coronary artery bypass grafting (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, CABG
- What is being tested?
- MSFP
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 May 2017to 1 Mar 2020
- 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: CABG
Who may be able to join
- Patients 18 years and older planned for CABG
Who cannot join
- Contraindication for fluid loading
- Pregnancy, morbid obesity
- Hemodynamic instability with a mean arterial pressure (MAP) < 55 mm Hg and/ or a cardiac index < 1.5 L•min-1
- Severe arrhythmias
- Intra-cardiac shunts
- Symptomatic peripheral vascular disease
Show all 12Show fewer
- Symptomatic pulmonary disease
- Significant valvular regurgitation
- Poor pre-operative left or right ventricular function
- Core temperature < 36 °C
- Contra-indication to the rapid cuff inflator
- Contra-indication to oesophageal Doppler probe insertion.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center Amsterdam
Amsterdam
Bart Geerts, MD, PhD, b.f.geerts@amc.uva.nl
Marije Wijnberge, MD
About this study
Official title: Measurement of Mean Systemic Filling Pressure & Stressed Volume With CardioQ+® Oesophageal Doppler Measurement
To study the reliablity of MSFP and stressed volume to follow volume loading and to predict fload loading responsiveness in patients after elective coronary artery bypass grafting (CABG) surgery.
Read the detailed description
In this study the oesophageal Doppler monitor (CardioQ+), arterial pulse wave analysis (via the CardioQ+ and Flotrac device) and central venous pressure (CVP) will be used to estimate mean systemic filling pressure (MSFP) with the inspiratory hold method. Furthermore the MSFParm will be determined using a rapid cuff inflator. From MSFP vascular compliance (Csys) and stressed volume (Vs) will be calculated.
The accuracy of Vs to follow a 500 increase in volume will be studied. The accuracy of MSFP and Vs to to predict fluid loading responsiveness will be assessed in 42 patients after elective coronary artery bypass grafting (CABG) surgery. The effect of a standardised fluid loading on parameters of intrinsic contractility and afterload will be determined. The effect of fluid loading on inertia, resistance and elastance will be assessed
- Conditions
- Cardiac Surgery, CABG
- Being tested
- MSFP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSFPDiagnostic test
MSFPhold and MSFParm
What is being measured
The primary outcome is the main question the study is designed to answer.
MSFPhold
Mean systemic filling pressure
Measured: Before and after fluid administration (2 minutes and 10 minutes)
MSFParm
Mean systemic filling pressure
Measured: Before and after fluid administration (2 minutes and 10 minutes)
Secondary outcomes (1)
Stressed volume
Vs
Measured: Before and after fluid administration (2 minutes and 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start9 May 2017
- Primary completion5 May 2019
- Study completion1 Mar 2020 (estimated)
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 SurgeryStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Bart Geerts, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139929
- Sponsor's protocol ID
- NL 55531.018.15
- Status last verified
- Jan 2020
- First submitted
- 3 Apr 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wijnberge M, Jansen JRC, Pinsky MR, Klanderman RB, Terwindt LE, Bosboom JJ, Lemmers N, Vlaar AP, Veelo DP, Geerts BF. Feasibility to estimate mean systemic filling pressure with inspiratory holds at the bedside. Front Physiol. 2022 Nov 29;13:1041730. doi: 10.3389/fphys.2022.1041730. eCollection 2022.
PubMed 36523553
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Mean Systemic Filling Pressure & Stressed Volume With CardioQ+® Oesophageal Doppler Measurement
- ClinicalTrials.gov ID
- NCT03139929
- Acronym / sponsor ID
- NL 55531.018.15
- Conditions
- Cardiac Surgery, CABG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 4 May 2017 (actual)
- 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.
To study the reliablity of MSFP and stressed volume to follow volume loading and to predict fload loading responsiveness in patients after elective coronary artery bypass grafting (CABG) surgery.
Detailed description
In this study the oesophageal Doppler monitor (CardioQ+), arterial pulse wave analysis (via the CardioQ+ and Flotrac device) and central venous pressure (CVP) will be used to estimate mean systemic filling pressure (MSFP) with the inspiratory hold method. Furthermore the MSFParm will be determined using a rapid cuff inflator. From MSFP vascular compliance (Csys) and stressed volume (Vs) will be calculated.
The accuracy of Vs to follow a 500 increase in volume will be studied. The accuracy of MSFP and Vs to to predict fluid loading responsiveness will be assessed in 42 patients after elective coronary artery bypass grafting (CABG) surgery. The effect of a standardised fluid loading on parameters of intrinsic contractility and afterload will be determined. The effect of fluid loading on inertia, resistance and elastance will be assessed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CABG
Key inclusion criteria (1 listed)
- Patients 18 years and older planned for CABG
Key exclusion criteria (12 listed)
- Contraindication for fluid loading
- Pregnancy, morbid obesity
- Hemodynamic instability with a mean arterial pressure (MAP) < 55 mm Hg and/ or a cardiac index < 1.5 L•min-1
- Severe arrhythmias
- Intra-cardiac shunts
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 |
|---|---|---|
| MSFPMSFPhold and MSFParm | Diagnostic test | – |
Primary outcome
MSFPhold
Time frame: Before and after fluid administration (2 minutes and 10 minutes)
Mean systemic filling pressure
MSFParm
Time frame: Before and after fluid administration (2 minutes and 10 minutes)
Mean systemic filling pressure
1 secondary outcome
Stressed volume
Time frame: Before and after fluid administration (2 minutes and 10 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 36523553Wijnberge M, Jansen JRC, Pinsky MR, Klanderman RB, Terwindt LE, Bosboom JJ, Lemmers N, Vlaar AP, Veelo DP, Geerts BF. Feasibility to estimate mean systemic filling pressure with inspiratory holds at the bedside. Front Physiol. 2022 Nov 29;13:1041730. doi: 10.3389/fphys.2022.1041730. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Bart Geerts, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Surgery and CABG, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 12 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Veelo, MD, PhD (020 566 9111 ext. 66478, d.p.veelo@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSFPhold (time frame: Before and after fluid administration (2 minutes and 10 minutes)). The study lists 2 primary outcomes in all. 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 NCT03139929, 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 13 Jan 2020.