NCT05188092 Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients
| NCT ID | NCT05188092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-12-22 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2021-12-22 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU patients. The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients. The investigators hypothesize that LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation. This study is an international multicenter randomized clinical trial (RCT) in invasively ventilated ICU patients.This study will include 1,000 consecutively admitted invasively ventilated adult ICU patients, who are expected not to be extubated within the next 24 hours after randomization. Patients are randomly assigned to the intervention group, in which fluid deresuscitation is guided by repeated LUS, or the control group, in which fluid deresuscitation is at the discretion of the treating physician (not using LUS).
Eligibility Criteria
Inclusion Criteria: * Admission to one of the participating ICUs; * Invasively ventilated for less than 24 hours at randomization; * Expected to be under invasive ventilation for longer than 24 hours after randomization. Exclusion Criteria: * 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 condition that can prolong duration of mechanical ventilation (i.e.Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis); * Conditions in which LUS cannot be performed or correctly interpreted (i.e. chest wall abnormalities, morbid obesity, and pre-existing interstitial lung disease); * Conditions in which targeting a negative fluid balance is discouraged (i.e. subarachnoid bleeding, severe rhabdomyolysis (CK \> 20.000); * Previous participation in this RCT; * Patients transferred from another center and invasively ventilated for longer than 24 hours.
Contact & Investigator
Marcus J Schultz, Prof
PRINCIPAL INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Frequently Asked Questions
Who can join the NCT05188092 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05188092 currently recruiting?
Yes, NCT05188092 is actively recruiting participants. Contact the research team at a.mousa1@amsterdamumc.nl for enrollment information.
Where is the NCT05188092 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands.
Who is sponsoring the NCT05188092 clinical trial?
NCT05188092 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Marcus J Schultz, Prof at Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 1,000 participants.