Cardiac SurgeryTESTINCT03926910
Ventricular Stimulation as Predictor of Hypovolemia After Cardiac Surgery
A study testing Detection of hypovolemia using a ventricular stimulation without atrial pacing in people with Cardiac Surgery and Hypovolemia, run by CMC Ambroise Paré at 1 site in France.
Trial summary
The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Hypovolemia
- What is being tested?
- Detection of hypovolemia using a ventricular stimulation without atrial pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2019to 14 Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Programmed for cardiac surgery with the need for invasive hemodynamic monitoring (pulmonary artery catheter) according to the recommendations:
- Euroscore with predicted mortality> 10%
- Left ventricular ejection fraction (LVEF) <40%
- Left ventricular ejection fraction (LVEF) <50% for mitral insufficiency
- pulmonary artery hypertension (PAH)> 50 mmHg
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- Tricuspid insufficiency> 3.4 m / s
- Tricuspid annular plane systolic excursion (TAPSE) <16 mm
- Dilatation of the inferior vena cava under respiratory collapse
- Sinus rhythm in immediate postoperative period,
- Sedated with mechanical ventilation,
- Having given their written participation consent in accordance with the regulations,
- Benefiting from a social security
Who cannot join
- Pregnant or lactating women,
- Patient under guardianship, Under curatorship or court of justice,
- Discomfort to communication or neuropsychic disorders,Inability to understand, to read or to write the French language,
- Patients for whom a fluids overload seems obvious to the intensivist and for whom a crystalloids filling would be contraindicated,
- Patients for whom respiratory changes in pulse pressure (ΔPP) measurement is not validated: patients with spontaneous ventilation, atrial fibrillation, non-sedated
Trial locations and contacts
1 site in 1 country.
France1 site
CMC Ambroise Paré
Neuilly-sur-Seine, Neuilly Sur Seine Ile de France, 92200
About this study
Official title: Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.
The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients.
Read the detailed description
In the immediate postoperative period of cardiac surgery and in intensive care unit (ICU), a systemic arterial hypotension is frequently observed. This hypotension is often due to hypovolemia but also to pump dysfunction and/or vasoplegia. Early recognition of the hypotensive mechanism is necessary because it requires immediate specific treatment.
The interest of a vascular filling is usually estimated by a preload dependence test (fluid responsiveness), showing an increase in the stroke volume when preload is increased according to the Starling the law of the heart. To date, a preload dependency test is usually performed by passive leg raise (PLR) or by measuring the respiratory pulse variation (ΔPP).
The PLR response varies according to the legs venous volume and capacitance. The derivation of ΔPP has been validated in patients intubated, sedated, and ventilated in standard conditions, in sinus rhythm but the ΔPP directly displayed by the monitors is unreliable and the manual calculation on pressure curve is fastidious. Faced with these difficulties, the trend is to realize a blind filling with physiologic saline solution and to judge his interest on clinical and / or hemodynamic criteria.
After cardiac surgery, ventricular epicardial electrodes are systematically placed allowing a temporary stimulation by an external pacemaker in case of postoperative atrio-ventricular blocks. The ventricular stimulation without atrial pacing (VESAP) leads to a loss of the atrial systole and therefore a decrease in the left ventricular preload. During the functional test of epicardial electrodes at a frequency greater than the patient's, it is possible to observe in certain circumstances a decrease of the arterial blood pressure, but of varying importance.
The investigators suspect that the eventual fall in blood pressure during a ventricular pacing test, could be correlated with preload dependence. Therefore, investigator hypothesize that ventricular pacing can be used to realize a functional testing of preload dependence, easy to achieve. Indeed, if doctors admit that during a brief ventricular stimulation, heart rate and systemic vascular resistance remain unchanged, the drop in blood pressure should reflect the decrease in stroke volume.
The main objective of this study is to demonstrate that the response to VESAP can predict the preload dependence of patients after a cardiac surgery. The primary endpoint will study the predictive value of the change in blood pressure during the VESAP and the change in stroke volume after an infusion of 500 cc of crystalloid solution. Secondary endpoints will 1) compare the predictive values of the VESAP and ΔPP; 2) look for pertinent VESAP threshold in correlation with the expected increase in stroke volume; and 3) collection of the possible complications due to the VESAP.
30 patients will be enrolled in this monocentric, open label, non-randomized study.
- Conditions
- Cardiac Surgery, Hypovolemia
- Being tested
- Detection of hypovolemia using a ventricular stimulation without atrial pacing
- Keywords
- Preload-dependency, hypotension, cardiac surgery, delta PP, PLR, Fluid responsiveness
- Medical subject headings
- Hypovolemia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of hypovolemia using a ventricular stimulation without atrial pacingDiagnostic test
Upon the return in intensive care:
- Baseline measurements: 1) Three measurements of blood pressure during inspiration and 3 during expiration will be collected for averaging systolic blood pressure, diastolic blood pressure, mean arterial pressure and ΔPP. Data from a pulmonary artery catheter will be also collected.
- Realization of VESAP pacing with adjustment of the pacemaker (PM) at a heart rate 5 bpm higher than the heart rate of the patient. After 20 seconds of stimulation, recording of the blood pressure curve as done at baseline during at least 3 respiratory cycles,
- Then vascular filling with 500 ml of physiologic saline solution over 10 minutes and new set of measurement (same than at baseline)
- Second realization of VESAP pacing, and new set of measurement (same than at Baseline)
- Then, if the ΔPP is >10%, new vascular filling with 500 ml of physiologic saline solution over 10 min and new set of measurements as previously performed.
| Study group | Role | What they receive |
|---|---|---|
| VESAP | Experimental | patient receiving stimulation test to detect hypovolemia Receives: Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation between thes stimulation test and the cardiac output
Measure the cardiac flow before and after the VESAP, and after an infusion of 500 cc of crystalloid solution.
Measured: 1 hour
Secondary outcomes (3)
Collection of the possible complications due to the VESAP
Number of participants with low blood presseur or with heart rhythm disorder.
Measured: 2 hours and 24 hours
Evaluate the correlation between the VESAP and the ΔP
Measure the of the blood presser before and after stimulation test and after an infusion of 500 cc of crystalloid solution
Measured: 1 hour
Look for pertinent VESAP threshold in correlation with the expected increase in stroke volume
Measure the of the strocke volume before and after stimulation test and after an infusion of 500 cc of crystalloid solution
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start22 Jul 2019
- Primary completion13 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 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
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ESTAGNASIÉ, MD, Principal investigator, CMC Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926910
- Sponsor's protocol ID
- 2018/13
- Acronym
- TESTI
- Status last verified
- Nov 2021
- First submitted
- 17 Apr 2019
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.
- ClinicalTrials.gov ID
- NCT03926910
- Acronym / sponsor ID
- TESTI / 2018/13
- Conditions
- Cardiac Surgery, Hypovolemia
- Keywords
- Preload-dependency, hypotension, cardiac surgery, delta PP, PLR, Fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 25 Apr 2019 (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.
The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients.
Detailed description
In the immediate postoperative period of cardiac surgery and in intensive care unit (ICU), a systemic arterial hypotension is frequently observed. This hypotension is often due to hypovolemia but also to pump dysfunction and/or vasoplegia. Early recognition of the hypotensive mechanism is necessary because it requires immediate specific treatment.
The interest of a vascular filling is usually estimated by a preload dependence test (fluid responsiveness), showing an increase in the stroke volume when preload is increased according to the Starling the law of the heart. To date, a preload dependency test is usually performed by passive leg raise (PLR) or by measuring the respiratory pulse variation (ΔPP).
The PLR response varies according to the legs venous volume and capacitance. The derivation of ΔPP has been validated in patients intubated, sedated, and ventilated in standard conditions, in sinus rhythm but the ΔPP directly displayed by the monitors is unreliable and the manual calculation on pressure curve is fastidious. Faced with these difficulties, the trend is to realize a blind filling with physiologic saline solution and to judge his interest on clinical and / or hemodynamic criteria.
After cardiac surgery, ventricular epicardial electrodes are systematically placed allowing a temporary stimulation by an external pacemaker in case of postoperative atrio-ventricular blocks. The ventricular stimulation without atrial pacing (VESAP) leads to a loss of the atrial systole and therefore a decrease in the left ventricular preload. During the functional test of epicardial electrodes at a frequency greater than the patient's, it is possible to observe in certain circumstances a decrease of the arterial blood pressure, but of varying importance.
The investigators suspect that the eventual fall in blood pressure during a ventricular pacing test, could be correlated with preload dependence. Therefore, investigator hypothesize that ventricular pacing can be used to realize a functional testing of preload dependence, easy to achieve. Indeed, if doctors admit that during a brief ventricular stimulation, heart rate and systemic vascular resistance remain unchanged, the drop in blood pressure should reflect the decrease in stroke volume.
The main objective of this study is to demonstrate that the response to VESAP can predict the preload dependence of patients after a cardiac surgery. The primary endpoint will study the predictive value of the change in blood pressure during the VESAP and the change in stroke volume after an infusion of 500 cc of crystalloid solution. Secondary endpoints will 1) compare the predictive values of the VESAP and ΔPP; 2) look for pertinent VESAP threshold in correlation with the expected increase in stroke volume; and 3) collection of the possible complications due to the VESAP.
30 patients will be enrolled in this monocentric, open label, non-randomized study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VESAP | Experimental | Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacingpatient receiving stimulation test to detect hypovolemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Over 18 years old,
- Programmed for cardiac surgery with the need for invasive hemodynamic monitoring (pulmonary artery catheter) according to the recommendations:
- Sinus rhythm in immediate postoperative period,
- Sedated with mechanical ventilation,
- Having given their written participation consent in accordance with the regulations,
Key exclusion criteria (5 listed)
- Pregnant or lactating women,
- Patient under guardianship, Under curatorship or court of justice,
- Discomfort to communication or neuropsychic disorders,Inability to understand, to read or to write the French language,
- Patients for whom a fluids overload seems obvious to the intensivist and for whom a crystalloids filling would be contraindicated,
- Patients for whom respiratory changes in pulse pressure (ΔPP) measurement is not validated: patients with spontaneous ventilation, atrial fibrillation, non-sedated
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 |
|---|---|---|
| Detection of hypovolemia using a ventricular stimulation without atrial pacingUpon the return in intensive care: * Baseline measurements: 1) Three measurements of blood pressure during inspiration and 3 during expiration will be collected for averaging systolic blood pressure, diastolic blood pressure, mean arterial pressure and ΔPP. Data from a pulmonary artery catheter will be also collected. * Realization of VESAP pacing with adjustment of the pacemaker (PM) at a heart rate 5 bpm higher than the heart rate of the patient. After 20 seconds of stimulation, recording of the blood pressure curve as done at baseline during at least 3 respiratory cycles, * Then vascular filling with 500 ml of physiologic saline solution over 10 minutes and new set of measurement (same than at baseline) * Second realization of VESAP pacing, and new set of measurement (same than at Baseline) * Then, if the ΔPP is >10%, new vascular filling with 500 ml of physiologic saline solution over 10 min and new set of measurements as previously performed. | Diagnostic test | VESAP |
Primary outcome
Evaluate the correlation between thes stimulation test and the cardiac output
Time frame: 1 hour
Measure the cardiac flow before and after the VESAP, and after an infusion of 500 cc of crystalloid solution.
3 secondary outcomes
Collection of the possible complications due to the VESAP
Time frame: 2 hours and 24 hours
Evaluate the correlation between the VESAP and the ΔP
Time frame: 1 hour
Look for pertinent VESAP threshold in correlation with the expected increase in stroke volume
Time frame: 1 hour
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 29 Nov 2021.
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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.
Philippe ESTAGNASIÉ, MD principal investigator
CMC Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of hypovolemia using a ventricular stimulation without atrial pacing in people with Cardiac Surgery and Hypovolemia, run by CMC Ambroise Paré at 1 site in France.
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 13 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 29 Nov 2021. 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 France. 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?
Evaluate the correlation between thes stimulation test and the cardiac output (time frame: 1 hour). 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 29 Nov 2021.