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出境医 / 临床实验 / Ventricular Stimulation as Predictor of Hypovolemia After Cardiac Surgery (TESTI)

Ventricular Stimulation as Predictor of Hypovolemia After Cardiac Surgery (TESTI)

Study Description
Brief Summary:
The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Hypovolemia Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacing Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 22, 2021
Estimated Study Completion Date : July 23, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: VESAP
patient receiving stimulation test to detect hypovolemia
 Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacing

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.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Collection of the possible complications due to the VESAP [ Time Frame: 2 hours and 24 hours ]
    Number of participants with low blood presseur or with heart rhythm disorder.

  2. Evaluate the correlation between the VESAP and the ΔP [ Time Frame: 1 hour ]
    Measure the of the blood presser before and after stimulation test and after an infusion of 500 cc of crystalloid solution

  3. Look for pertinent VESAP threshold in correlation with the expected increase in stroke volume [ Time Frame: 1 hour ]
    Measure the of the strocke volume before and after stimulation test and after an infusion of 500 cc of crystalloid solution


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Philippe ESTAGNASIÉ, MD (+33) 01 46 41 89 71 philippe.estagnasie@wanadoo.fr
Contact: Pierre SQUARA, MD (+33) 01 46 41 89 71 pierre.squara@orange.fr

Locations
Layout table for location information
France
CMC Ambroise Paré Recruiting
Neuilly-sur-Seine, Neuilly Sur Seine Ile De France, France, 92200
Contact: Fatma BOUAZIZ, CTA       recherche@clinique-a-pare.fr   
Principal Investigator: Philippe ESTAGNASIE, MD         
Sponsors and Collaborators
CMC Ambroise Paré
Investigators
Layout table for investigator information
Principal Investigator: Philippe ESTAGNASIÉ, MD CMC Ambroise Paré
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date July 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		Evaluate the correlation between thes stimulation test and the cardiac output [ Time Frame: 1 hour ]
Mesure the cardiac flow before and after the VESAP, and after an infusion of 500 cc of crystalloid solution.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Collection of the possible complications due to the VESAP [ Time Frame: 2 hours and 24 hours ]
    Number of participants with low blood presseur or with heart rhythm disorder.
  • Evaluate the correlation between the VESAP and the ΔP [ Time Frame: 1 hour ]
    Measure the of the blood presser before and after stimulation test and after an infusion of 500 cc of crystalloid solution
  • Look for pertinent VESAP threshold in correlation with the expected increase in stroke volume [ Time Frame: 1 hour ]
    Measure the of the strocke volume before and after stimulation test and after an infusion of 500 cc of crystalloid solution
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Collection of the possible complications due to the VESAP [ Time Frame: 2 hours and 24 hours ]
    Nomber of participants with low blood presseur or with heart rhythm disorder.
  • Evaluate the correlation betwen the VESAP and the ΔP [ Time Frame: 1 hour ]
    Mesure the of the blood pressure before and after stimilation test and after an infusion of 500 cc of crystalloid solution
  • Look for pertinent VESAP threshold in correlation with the expected increase in stroke volume [ Time Frame: 1 hour ]
    Mesure the of the strock volume before and after stimilation test and after an infusion of 500 cc of crystalloid solution
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ventricular Stimulation as Predictor of Hypovolemia After Cardiac Surgery
Official Title  ICMJE Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cardiac Surgery
  • Hypovolemia
Intervention  ICMJE Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacing

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 Arms  ICMJE Experimental: VESAP
patient receiving stimulation test to detect hypovolemia
Intervention: Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 23, 2021
Estimated Primary Completion Date July 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philippe ESTAGNASIÉ, MD (+33) 01 46 41 89 71 philippe.estagnasie@wanadoo.fr
Contact: Pierre SQUARA, MD (+33) 01 46 41 89 71 pierre.squara@orange.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926910
Other Study ID Numbers  ICMJE 2018/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CMC Ambroise Paré
Study Sponsor  ICMJE CMC Ambroise Paré
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe ESTAGNASIÉ, MD CMC Ambroise Paré
PRS Account CMC Ambroise Paré
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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