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

• Conditions: Breathing

• Registration Number: NCT03780660
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Study Start: 2019-03-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France