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

NCT03780660 | Completed

• 2 other identifiers: 2017_602018-A01449-46
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the area under the ROC curve of the "CVPV-un" parameter

  an average 60 - 90 minute during the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Related Publications (1)

• Bourel C, Durand A, Ter Schiphorst B, Martin C, Onimus T, De Jonckheere J, Howsam M, Pierre A, Favory R, Preau S. RESPIRATION-RELATED VARIATIONS IN CENTRAL VENOUS PRESSURE AS PREDICTORS OF FLUID RESPONSIVENESS IN SPONTANEOUSLY BREATHING PATIENTS. Shock. 2023 Aug 1;60(2):190-198. doi: 10.1097/SHK.0000000000002164. Epub 2023 Jul 26.

  PMID: 37548683 RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Sébastien Preau, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: March 5, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (1)