Analyzing the effects of fluid bolus treatment in shock patients
Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS - the PHOEBUS Study
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bicetre Hospital Academic / other |
| Locations | 1 site (Le Kremlin-Bicêtre) |
| Trial ID | NCT06839404 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant or those who refuse participation will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Le Kremlin-Bicêtre
- Bicêtre Hospital — Le Kremlin-Bicêtre, France (Recruiting)
Study contacts
- Study coordinator: Xavier Monnet, MD, PhD
- Email: xavier.monnet@aphp.fr
- Phone: +33660862669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.