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Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients

ConditionsMechanical VentilationFluid OverloadDeresuscitationVentilator-free Days
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age below 18 years old;

Suspected or confirmed pregnancy;

Participation in other interventional trials with similar endpoints;

Use of long term home mechanical ventilation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lung ultrasound guided deresuscitation

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventilator free days(VFD) and alive at day 28

Patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours: * VFD-28 = 0 if subject dies within 28 days of mechanical ventilation * VFD-28 = 28 - x if successfully liberated from ventilation x days after initiation Succcessful liberation: extubation (planned or unplanned) without death or reintubation within the next 72 hours * VFD-28 = 0 if the subject is mechanically ventilated for ≥ 28 days

Time frame
28 days after randomisation

Secondary outcomes

1

Duration of ventilation

Duration of ventilation in survivors

Time frame
28 days
2

ICU length of stay

Length of stay in the intensive care unit

Time frame
28 days
3

Hospital length of stay

Length of stay in the hospital

Time frame
28 days
4

28 day mortality

Mortality after 28 days

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Source ClinicalTrials.gov
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