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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Amsterdam UMC, location VUMC
RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Contact Information
Primary
Amne Mousa, MSc
a.mousa1@amsterdamumc.nl
06 500 876 37
Backup
Siebe G Blok, MD, MSc
s.blok@amsterdamumc.nl
06 500 876 37
Time Frame
Start Date: 2021-12-22
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 1000
Treatments
No_intervention: Control
Routine fluid deresuscitation in which fluid withdrawal is started and continued at the discretion of the treating physician.
Active_comparator: Intervention
Deresuscitation is guided by lung ultrasound observations.
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov