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

Breathing Clinical Trial

— VPVC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03780660
• Other study ID #: 2017_60
• Secondary ID: 2018-A01449-46
• Status: Recruiting
• Start date: March 5, 2019
• Est. completion date: February 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: Sébastien Preau, MD
• Phone: 03.20.44.44.95
• Email: sebastien.preau[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breathing
• Respiratory Aspiration

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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