Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients

NCT05188092 | Recruiting DMC

• 1 other identifier: CONFIDENCE
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

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).

Conditions

Deresuscitation; Ventilator-free Days; Mechanical Ventilation; Fluid Overload

Outcome Measures

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

  28 days after randomisation

Secondary Outcomes (9)

• Duration of ventilation

  28 days

• ICU length of stay

  28 days

• Hospital length of stay

  28 days

• 28 day mortality

  28 days

• 90 day mortality

  90 days

Study Arms (2)

Control

NO INTERVENTION

Routine fluid deresuscitation in which fluid withdrawal is started and continued at the discretion of the treating physician.

Intervention

ACTIVE COMPARATOR

Deresuscitation is guided by lung ultrasound observations.

Other: Lung ultrasound guided deresuscitation

Interventions

Lung ultrasound guided deresuscitation OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (3)

Rijnstate

Arnhem, Gelderland, 6800 TA, Netherlands

RECRUITING

Amsterdam UMC, location VUMC

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

• Blok SG, Mousa A, Brouwer MG, de Grooth HJ, Neto AS, Blans MJ, den Boer S, Dormans T, Endeman H, Roeleveld T, Scholten H, van Slobbe-Bijlsma ER, Scholten E, Touw H, van der Ven FSLIM, Wils EJ, van Westerloo DJ, Heunks LMA, Schultz MJ, Paulus F, Tuinman PR. Effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients (CONFIDENCE): protocol for a multicentre randomised controlled trial. Trials. 2023 Mar 24;24(1):226. doi: 10.1186/s13063-023-07171-w.

  PMID: 36964614 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcus J Schultz, Prof

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

  PRINCIPAL INVESTIGATOR

• Pieter Roel Tuinman, Dr

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Frederique Paulus, Dr

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

  STUDY DIRECTOR

• Leo MA Heunks

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Central Study Contacts

Amne Mousa, MSc

CONTACT

06 500 876 37; a.mousa1@amsterdamumc.nl

Siebe G Blok, MD, MSc

CONTACT

06 500 876 37; s.blok@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. M.J. Schultz

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 12, 2022
• Study Start: December 22, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (3)