Actively Recruiting

Age: 18Years +
All Genders
NCT06839404

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS

Led by Bicetre Hospital · Updated on 2025-02-21

500

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6518 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
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Refusal to participate by relatives of the patient or the patient himself
  • Other therapeutic modification during volume expansion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Bicêtre Hospital

Le Kremlin-Bicêtre, France, 94320

Actively Recruiting

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Research Team

X

Xavier Monnet, MD, PhD

CONTACT

C

Christopher Lai, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS | DecenTrialz