Clinical trial NCT03780660: Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients
Official title: Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breathing
Keywords: Volume expansion
fluid responsiveness
critically ill patient
spontaneously breathing patient
central venous pressure variation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalized in one of intensive care unit of Roger Salengro university hospital CHU Lille

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.


Eligibility criteria: 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

Primary outcomes:
measure: the area under the ROC curve of the "CVPV-st" parameter
timeFrame: an average 60 - 90 minute during the procedure
Secondary outcomes:
measure: the area under the ROC curve of the "CVPV-un" parameter
timeFrame: an average 60 - 90 minute during the procedure
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Sébastien Preau, MD
role: PRINCIPAL_INVESTIGATOR
References: