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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03780660

Acronym

VPVC

Enrollment

Registered

2018-12-19

Start date

2019-03-05

Completion date

2021-09-15

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing

Keywords

Volume expansion, fluid responsiveness, critically ill patient, spontaneously breathing patient, central venous pressure variation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results