Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05898269

Fluid Responsiveness Prediction During Prone Position

Led by Hospices Civils de Lyon · Updated on 2024-01-18

96

Participants Needed

4

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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). These elements warrant the development of specific tests allowing the clinician to predict fluid responsiveness with enough exactitude when caring for these patients. We hypothesize that there exists diagnostic heterogeneity in the predictive performance of 4 clinical tests to identify fluid responsiveness in ARDS patients in PP. For the matter of this study, these 4 tests are the Trendelenburg maneuver, the end-expiratory occlusion test, the end-expiratory occlusion test associated with the end-inspiratory occlusion test, and the tidal volume challenge. The diagnostic reference of the study will be the relative change in cardiac index measured by transpulmonary thermodilution before and after a 500 ml fluid bolus, and will allow the adjudication of patients as being fluid responsive or not. The primary objective of the study is to determine the area under the ROC curve of each of the 4 tests, with their respective 95% confidence interval. All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. Patients will only participate once. The expected duration of study participation is 30 minutes maximum.

CONDITIONS

Official Title

Fluid Responsiveness Prediction During Prone Position

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient (including patient under protective measures/wardship)
  • Diagnosed with ARDS as defined by the Berlin criteria
  • Currently placed in the prone position according to international guidelines
  • Equipped with a calibrated continuous cardiac output monitoring device
  • Has a clinical indication for a fluid bolus prescribed by the clinician and meets at least two clinical signs such as mottles, tachycardia, hypotension, drop in cardiac output, oliguria, or high arterial lactate concentration
  • No respiratory efforts present
Not Eligible

You will not qualify if you...

  • Acute cor pulmonale
  • Receiving veno-venous extra-corporeal membrane oxygenation treatment
  • Experiencing hemorrhagic shock
  • Diagnosed with Child-Pugh C cirrhosis
  • Expected death within less than 24 hours
  • Decision to withhold or suspend active treatments
  • Intracranial hypertension
  • Lower limb amputation
  • Obstruction of the inferior vena cava
  • Acute abdominal syndrome
  • No consent to participate
  • Pregnancy
  • Previously enrolled in the same study
  • Lack of affiliation to a social security regimen as per French legislation
  • Deprived of liberty

AI-Screening

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Trial Site Locations

Total: 4 locations

1

CHU Gabriel Montpied

Clermont-Ferrand, France, 63000

Not Yet Recruiting

2

Hôpital de la Croix Rousse, Hospices Civils de Lyon

Lyon, France, 69004

Actively Recruiting

3

CHU de Nice - l'Archet 1

Nice, France, 06200

Not Yet Recruiting

4

CHU Nice - Pasteur 2

Nice, France, 06200

Not Yet Recruiting

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Research Team

L

Laurent BITKER, Dr

CONTACT

M

Mathieu Jozwiak, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

24

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