Ventricular Stimulation as Predictor of Hypovolemia After Cardiac Surgery

NCT03926910 | Completed

• 1 other identifier: 2018/13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Hypovolemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (3)

• Collection of the possible complications due to the VESAP

  2 hours and 24 hours

• Evaluate the correlation between the VESAP and the ΔP

  1 hour

• Look for pertinent VESAP threshold in correlation with the expected increase in stroke volume

  1 hour

Study Arms (1)

VESAP

EXPERIMENTAL

patient receiving stimulation test to detect hypovolemia

Diagnostic Test: Detection of hypovolemia using a ventricular stimulation without atrial pacing

Interventions

Detection of hypovolemia using a ventricular stimulation without atrial pacing 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.

VESAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Neuilly Sur Seine Ile de France, 92200, France

Location

MeSH Terms

Conditions

Hypovolemia; Hypotension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Philippe ESTAGNASIÉ, MD

  CMC Ambroise Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 25, 2019
• Study Start: July 22, 2019
• Primary Completion: October 13, 2020
• Study Completion: October 14, 2020
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

FR (1)