Skip to main content
OpenTrials
Completed

NCT Number: NCT03780660

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breathing Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the area under the ROC curve of the "CVPV-st" parameter

    Time frame: 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 outcomes

  1. the area under the ROC curve of the "CVPV-un" parameter

    Time frame: an average 60 - 90 minute during the procedure

    Diagnostic accuracy of the CVPV during an unstandardized inspiratory maneuver (CVPV-un) to predict fluid responsiveness.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: VPVC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.