Study on Lung Ultrasound-Guided Fluid Removal to Reduce Ventilation Time in ICU Patients
A Randomized Clinical Trial Comparing Ultrasound-Guided and Routine Fluid Management
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-12-05
1000
Participants Needed
3
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of using lung ultrasound LUS to guide fluid removal deresuscitation on how long patients need invasive mechanical ventilation in intensive care units ICUs. This international multicenter randomized clinical trial aims to determine if LUS-guided fluid deresuscitation can reduce the duration of ventilation compared to routine care without LUS. The study includes adult ICU patients who are invasively ventilated and expected to remain on ventilation for more than 24 hours after enrollment.
Participants are randomly assigned to one of two groups. The intervention group receives fluid deresuscitation guided by daily lung ultrasound exams performed by trained healthcare providers, assessing lung fluid overload and pleural effusions to adjust fluid removal targets. The control group receives routine fluid deresuscitation managed by the treating physician using standard clinical assessments and tests without lung ultrasound guidance. Both groups follow standard criteria for extubation and ongoing monitoring. The study plans to enroll 1,000 patients.
During the study, patients are monitored for safety by an independent board. Lung ultrasound examinations are performed daily in the intervention group until day 28 or hospital discharge to detect fluid changes. Researchers will measure ventilator-free days at 28 days after randomization as the primary outcome, along with secondary outcomes including duration of ventilation, ICU and hospital stay length, mortality rates, reintubation rates, fluid balances, and kidney injury. Participation involves randomization soon after ICU admission and follow-up for up to 28 days with regular clinical assessments and monitoring.
CONDITIONS
Brief Title
Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients
Research Team
A
Amne Mousa, MSc
S
Siebe G Blok, MD, MSc
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Conditions where targeting negative fluid balance is discouraged (e.g., subarachnoid bleeding, severe rhabdomyolysis with CK > 20,000)
Previous participation in this trial
Patients transferred from another center and invasively ventilated for longer than 24 hours
Your Study Journey
Screening
Duration - Up to 48 hours after meeting ICU admission criteria
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Until extubation or up to 28 days
Participants receive either lung ultrasound guided fluid deresuscitation or routine fluid deresuscitation during their ICU stay while invasively ventilated.
Daily assessments with lung ultrasound in the intervention group; routine clinical assessments in the control group
Follow-up
Duration - Up to 90 days after randomization
Participants are monitored for safety and outcomes up to 90 days after randomization.
Follow-up visits or assessments as per clinical care
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients (CONFIDENCE): protocol for a multicentre randomised controlled trial.