RecruitingNot ApplicableNCT05188092

Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients

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


Sponsor

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

Enrollment

1,000 participants

Start Date

Dec 22, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using lung ultrasound to guide fluid removal (de-resuscitation) in ICU patients on mechanical ventilation can improve outcomes. Many critically ill patients receive large amounts of IV fluids during resuscitation; helping the body get rid of excess fluid afterwards may reduce complications like lung congestion and shorten time on the ventilator. You may be eligible if: - You are 18 years or older - You have been admitted to one of the participating ICUs - You are on invasive mechanical ventilation for less than 24 hours at the time of randomization - You are expected to remain on ventilation for more than 24 hours after randomization You may NOT be eligible if: - You are under 18 - You are pregnant - You use long-term home mechanical ventilation - You have a neurological condition likely to prolong ventilation (e.g., Guillain-Barré, ALS, high spinal cord injury, multiple sclerosis, myasthenia gravis) - You have chest wall abnormalities, severe obesity, or pre-existing interstitial lung disease that would interfere with lung ultrasound - You have a condition where targeting a negative fluid balance is dangerous (e.g., subarachnoid bleeding or severe rhabdomyolysis) - You have participated in this RCT before or were transferred from another center after 24+ hours of ventilation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLung ultrasound guided deresuscitation

With every new LUS examination, the following scenarios, with distinct recommendations, are possible: 1. LUS observations suggest massive pulmonary fluid overload, with the recommendation to minimize fluid infusion and start fluid withdrawal, targeting a negative fluid balance of at least -1500 ml in the next 24 hours; 2. LUS suggests some pulmonary edema and/or significant pleural effusion. These LUS observations suggest little pulmonary fluid overload, with the suggestion to minimize fluid infusion and start fluid withdrawal, targeting a negative fluid balance at least -500 ml in the next 24 hours; 3. LUS suggests absence of pulmonary edema and no pleural effusion. These LUS observations suggest no fluid overload, with the suggestion to target a neutral fluid balance in the next 24 hours.


Locations(3)

Rijnstate

Arnhem, Gelderland, Netherlands

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

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NCT05188092


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