Analyzing the effects of fluid bolus treatment in shock patients
Official title: Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS - the PHOEBUS Study
Run by Bicetre Hospital · NCT06839404 · Data updated 2026-11-12
This study is testing how well giving extra fluids helps hospitalized patients in shock by looking at how it affects their heart's ability to pump blood.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Bicetre Hospital Academic / other |
| Locations | 1 site (Le Kremlin-Bicêtre) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | February 21, 2025 |
| Trial ID | NCT06839404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are hospitalized in intensive care and require volume expansion due to shock.
✕Probably not a fit
Patients who are pregnant or those who refuse participation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the haemodynamic effects of administering a standard fluid bolus to patients experiencing shock. It aims to determine the effectiveness of volume expansion through intravenous fluid administration and to identify how much of the fluid administered is actually effective in increasing cardiac output. The study will involve patients aged 18 and older who are hospitalized in intensive care and already have haemodynamic monitoring in place. By analyzing the data collected, the study seeks to provide insights into the optimal management of fluid resuscitation in shock.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients in shock, enhancing their recovery and outcomes.
How similar studies have gone: While the approach of analyzing fluid bolus effects is common, the specific focus on quantifying ineffective volume in a large population is less explored, making this study somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Bicêtre Hospital
Le Kremlin-Bicêtre, France Recruiting
Study contacts
- Study coordinator: Xavier Monnet, MD, PhD
- Email: xavier.monnet@aphp.fr
- Phone: +33660862669
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.