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)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1,000 participants
Dec 22, 2021
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
Inclusion Criteria3
- 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 Criteria9
- 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.
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Interventions
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)
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NCT05188092