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Clinical Trials in France / NCT06839404
Recruiting Observational

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS

NCT06839404 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-07-01
Last updated
2025-02-21

Condition(s) studied

Shock

Investigational drug(s) / intervention(s)

fluid challenge →

fluid challenge: Fluid bolus of 500 mL of crystalloids given at a constant rate between 10 and 15 minutes

Study summary

When the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. This treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 mL of fluid over approximately 10 to 30 minutes. The injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects.

However, this treatment poses two problems. First, it is only inconsistently effective. It is possible that of the 250-500 mL of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly.

However, the average part of the total volume that is ineffective on a large population of patients is not well known.

Second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. However, the average duration of effectiveness of a 250-500 mL fluid bolus, and the factors that influence this duration of effectiveness, are not well determined.

The main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. The secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years old * Hospitalisation in intensive care * Haemodynamic monitoring already in place with a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated) * Decision taken by the clinicians in charge of the patient to perform volume expansion by intravenous infusion of a 6 mL/kg crystalloid bolus Exclusion Criteria: * Pregnancy * Refusal to participate by relatives of the patient or the patient himself * Other therapeutic modification during volume expansion

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Bicêtre Hospital Le Kremlin-Bicêtre France Recruiting

More Bicetre Hospital trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06839404 on ClinicalTrials.gov ↗ ← All trials in France