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New treatment option for Acute Respiratory Distress Syndrome
Official title Fluid Responsiveness Prediction During Prone Position
ClinicalTrials.gov ID: NCT05898269
What this study is testing
- What it's testing
- Predicting fluid responsiveness is primordial when caring for patients with circulatory shock as it allows correction of preload-dependent low cardiac output states, while preserving patients of the deleterious effects of excessive fluid resuscitation. Patients with severe acute respiratory distress syndrome (ARDS) treated with prone positioning (PP) are a specific subset of patients, as 1) they frequently present with shock; 2) excessive fluid administration may lead to respiratory worsening due to increased hydrostatic oedema with potential subsequent worse clinical outcome; and 3) all available dynamic tests evaluating fluid responsiveness can only be performed in patients in the supine condition (which in the case of severe ARDS patients in PP occurs only for 8h over 24h).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- with no respiratory efforts
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Lyon, France
- Nice, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Lyon, France; Nice, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.