Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05188092

Effect of Lung Ultrasound-Guided Fluid Deresuscitation on Duration of Ventilation in Intensive Care Unit Patients (CONFIDENCE)

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

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to one of the participating intensive care units (ICUs)
  • Invasively ventilated for less than 24 hours at the time of randomization
  • Expected to require invasive ventilation for longer than 24 hours after randomization
Not Eligible

You will not qualify if you...

  • Age below 18 years old
  • Suspected or confirmed pregnancy
  • Participation in other interventional trials with similar endpoints
  • Use of long-term home mechanical ventilation
  • Neurological conditions that can prolong mechanical ventilation (e.g., Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis)
  • Conditions preventing lung ultrasound or correct interpretation (e.g., chest wall abnormalities, morbid obesity, pre-existing interstitial lung disease)
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 3 locations

1

Rijnstate

Arnhem, Gelderland, Netherlands, 6800 TA

Actively Recruiting

2

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands, 1081 HV

Actively Recruiting

3

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105AZ

Actively Recruiting

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Research Team

A

Amne Mousa, MSc

S

Siebe G Blok, MD, MSc

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.

Siebe G Blok, Amne Mousa, Michelle G Brouwer...

https://pubmed.ncbi.nlm.nih.gov/36964614