Predicting fluid responsiveness in patients with acute respiratory distress syndrome in prone position
Evaluation of the Diagnostic Performance of 4 Dynamic Tests Evaluating Preload Dependence in Patients With Acute Respiratory Distress Syndrome in the Prone Position
This study is testing new ways to see if patients with acute respiratory distress syndrome in a face-down position need more fluids to help them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Clermont-Ferrand and 3 other locations) |
| Trial ID | NCT05898269 on ClinicalTrials.gov |
What this trial studies
This study aims to develop specific tests to predict fluid responsiveness in patients with acute respiratory distress syndrome (ARDS) who are positioned prone. It addresses the challenges of assessing fluid responsiveness in these patients, as traditional methods can only be performed when they are supine. The study will utilize various interventions, including the Trendelenburg maneuver and occlusion tests, to evaluate cardiac output and preload. By accurately predicting fluid needs, the study seeks to improve patient outcomes and minimize the risks associated with excessive fluid resuscitation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with ARDS who are currently in the prone position and require fluid resuscitation.
Not a fit: Patients with conditions such as acute cor pulmonale, hemorrhagic shock, or those expected to die within 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of fluid resuscitation in ARDS patients, potentially enhancing their recovery and reducing complications.
How similar studies have performed: While the approach of predicting fluid responsiveness in prone patients is relatively novel, similar studies have shown promise in improving fluid management in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patient (including patient under protective measures/wardship) * with ARDS as defined by the Berlin criteria * in the prone position as per international guidelines * with a calibrated continuous cardiac output monitoring device * with a clinical indication for a fluid bolus as prescribed by the clinician in charge, and fulfilling at least 2 clinical criteria: mottles, tachycardia, hypotension, drop in cardiac output, oliguria, high arterial lactate concentration, or any other detailed criterion * with no respiratory efforts Exclusion Criteria: * acute cor pulmonale * patient treated with veno-venous extra-corporeal membrane oxygenation * hemorrhagic shock * Child-Pugh C cirrhosis * death expected to occur in less than 24h * decision to withhold or suspend active treatments * intracranial hypertension * lower limb amputation * obstruction of the inferior vena cava * acute abdominal syndrome * absence of consent to participate * pregnancy * patient previously enrolled in the same study * lack of affiliation to a social security regimen, as per French legislation * patient deprived of its liberty
Where this trial is running
Clermont-Ferrand and 3 other locations
- CHU Gabriel Montpied — Clermont-Ferrand, France (Not_yet_recruiting)
- Hôpital de la Croix Rousse, Hospices Civils de Lyon — Lyon, France (Recruiting)
- CHU de Nice - l'Archet 1 — Nice, France (Not_yet_recruiting)
- CHU Nice - Pasteur 2 — Nice, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Hodane YONIS, Dr — Hospices Civils de Lyon
- Study coordinator: Laurent BITKER, Dr
- Email: laurent.bitker@chu-lyon.fr
- Phone: 4 26 10 94 93
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.