NCT06839404 Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS
| NCT ID | NCT06839404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bicetre Hospital |
| Condition | Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06839404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839404 currently recruiting?
Yes, NCT06839404 is actively recruiting participants. Contact the research team at xavier.monnet@aphp.fr for enrollment information.
Where is the NCT06839404 trial being conducted?
This trial is being conducted at Le Kremlin-Bicêtre, France.
Who is sponsoring the NCT06839404 clinical trial?
NCT06839404 is sponsored by Bicetre Hospital. The trial plans to enroll 500 participants.