Coronary Artery Bypass GraftNCT03002129
FLuid Responsiveness Prediction Using EXtra Systoles
A study testing fluid challenge in people with Coronary Artery Bypass Graft, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft
- What is being tested?
- fluid challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to Sep 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring elective CABG or OPCAB surgery
- Patient's age ≥ 18 years
Who cannot join
- Patient refusal
- Pregnancy
- EF < 35%
- End stage kidney failure (defined by the need for haemodialysis)
- Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.
Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids
- Conditions
- Coronary Artery Bypass Graft
- Being tested
- fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid challengeOther
At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| fluid challenge | Other | Not described Receives: Other: fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid challenge response in stroke volume
To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion26 Jun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr.T.W.L.Scheeren, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002129
- Sponsor's protocol ID
- FLEx study
- Status last verified
- May 2018
- First submitted
- 15 Dec 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holmgaard F, Vistisen ST, Ravn HB, Scheeren TWL. The response of a standardized fluid challenge during cardiac surgery on cerebral oxygen saturation measured with near-infrared spectroscopy. J Clin Monit Comput. 2020 Apr;34(2):245-251. doi: 10.1007/s10877-019-00324-w. Epub 2019 May 28.
PubMed 31134474Vistisen ST, Berg JM, Boekel MF, Modestini M, Bergman R, Jainandunsing JS, Mariani MA, Scheeren TWL. Using extra systoles and the micro-fluid challenge to predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2019 Oct;33(5):777-786. doi: 10.1007/s10877-018-0218-0. Epub 2018 Nov 9.
PubMed 30414054
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLuid Responsiveness Prediction Using EXtra Systoles
- ClinicalTrials.gov ID
- NCT03002129
- Acronym / sponsor ID
- FLEx study
- Conditions
- Coronary Artery Bypass Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Dec 2016 (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.
In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.
Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluid challenge | Other | Other: fluid challenge |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring elective CABG or OPCAB surgery
- Patient's age ≥ 18 years
Key exclusion criteria (5 listed)
- Patient refusal
- Pregnancy
- EF < 35%
- End stage kidney failure (defined by the need for haemodialysis)
- Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)
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 |
|---|---|---|
| fluid challengeAt two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes | Other | fluid challenge |
Primary outcome
fluid challenge response in stroke volume
Time frame: during operation
To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume
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 18 May 2018.
- Derived from this study: PubMed 31134474Holmgaard F, Vistisen ST, Ravn HB, Scheeren TWL. The response of a standardized fluid challenge during cardiac surgery on cerebral oxygen saturation measured with near-infrared spectroscopy. J Clin Monit Comput. 2020 Apr;34(2):245-251. doi: 10.1007/s10877-019-00324-w. Epub 2019 May 28.
- Derived from this study: PubMed 30414054Vistisen ST, Berg JM, Boekel MF, Modestini M, Bergman R, Jainandunsing JS, Mariani MA, Scheeren TWL. Using extra systoles and the micro-fluid challenge to predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2019 Oct;33(5):777-786. doi: 10.1007/s10877-018-0218-0. Epub 2018 Nov 9.
- 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.
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 fluid challenge in people with Coronary Artery Bypass Graft, run by University Medical Center Groningen 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 2 inclusion and 5 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 18 May 2018. 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?
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?
fluid challenge response in stroke volume (time frame: during operation). 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 NCT03002129, which also lists 2 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 18 May 2018.