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

NCT ID: NCT03780660

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-05

Study Completion Date

2021-09-15

Brief Summary

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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

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Conditions

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Breathing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Preau, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 37548683 (View on PubMed)

Other Identifiers

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2018-A01449-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_60

Identifier Type: -

Identifier Source: org_study_id

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