Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients (VPVC)

Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.

Central venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.

Study Overview

• Status: Unknown
• Conditions: Breathing

• Study Type: Observational
• Enrollment (Anticipated): 68

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Roger Salengro, CHU
    • Principal Investigator: Sébastien Preau, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized in one of intensive care unit of Roger Salengro university hospital CHU Lille

Description

Inclusion Criteria

• Spontaneous breathing without mechanical assistance
• Central venous catheter (superior vena cava) and monitoring of central venous pressure
• Urinary catheter and monitoring of intra-abdominal pressure

Exclusion Criteria:

• Intolerance to ventilatory manœuvre including Severe basal dyspnea/Symptomatic heart failure (pulmonary edema)
• Contraindication to passive leg raising (intracranial hypertension)
• Passive leg raising unsuitable for measuring hemodynamic response : High grade aortic insufficiency/ Poor echogenicity unsuitable to measure the velocity-time /integral of aortic blood flow/ Pregnancy/Abdominal hypertension with abdominal compartment syndrome/ Lower leg amputation
• Necessity of urgent hemodynamic therapy (within 90 min)
• Modification of hemodynamic therapy during study protocol (vascular filling, increase catecholamine dose

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the area under the ROC curve of the "CVPV-st" parameter	Diagnostic accuracy of the CVPV during a standardized inspiratory maneuver (CVPV-st) to predict fluid responsiveness.	an average 60 - 90 minute during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the area under the ROC curve of the "CVPV-un" parameter	Diagnostic accuracy of the CVPV during an unstandardized inspiratory maneuver (CVPV-un) to predict fluid responsiveness.	an average 60 - 90 minute during the procedure

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2019
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: fluid responsiveness; critically ill patient; Volume expansion; spontaneously breathing patient; central venous pressure variation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2017_60; 2018-A01449-46 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No