Ventricular Stimulation as Predictor of Hypovolemia After Cardiac Surgery

NCT ID: NCT03926910

Last Updated: 2021-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2020-10-14

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.

Conditions

Cardiac Surgery; Hypovolemia

Keywords

Preload-dependency; hypotension; cardiac surgery; delta PP; PLR; Fluid responsiveness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

VESAP

patient receiving stimulation test to detect hypovolemia

Group Type: EXPERIMENTAL

Detection of hypovolemia using a ventricular stimulation without atrial pacing

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe ESTAGNASIÉ, MD

Role: PRINCIPAL_INVESTIGATOR

CMC Ambroise Paré

Locations

CMC Ambroise Paré

Neuilly-sur-Seine, Neuilly Sur Seine Ile de France, France

Countries

France

Other Identifiers

2018/13

Identifier Type: -

Identifier Source: org_study_id