Research with human participants

Overview of medical research in the Netherlands

*EffeCt of lung ultrasOuNd-guided Fluid deresuscItation on Duration of vEntilation iN intensive Care unit patiEnts (CONFIDENCE-trial)*

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Last updated:

LUS-guided fluid deresuscitation is superior to standard fluid deresuscitation without LUS with regard to duration of invasive ventilation

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Other condition
Study type
Interventional

ID

NL-OMON54414

Source

ToetsingOnline

Brief title

CONFIDENCE

Condition

  • Other condition

Synonym

mechanical ventilation, respiratory failure

Health condition

respiratory failure

Research involving

Human

Sponsors and support

Primary sponsor :
Amsterdam UMC
Source(s) of monetary or material Support :
ZonMw

Intervention

Keyword :
Deresuscitation, Intensive Care, mechanical ventilation, Ultrasound

Outcome measures

Primary outcome

Number of ventilator-free days and alive at day 28 (*VFD-28*)

Secondary outcome

ICU- and hospital length of stay; ICU-, hospital- and 90-day mortality;

cumulative fluid balance at successive days; proportion of patients who develop

kidney injury or atrial fibrillation.

Background summary

Timely recognition of pulmonary edema will lead to earlier extubation in
intensive care unit (ICU) patients. Lung ultrasound (LUS) is a simple, safe
non-invasive bedside imaging tool with high accuracy for pulmonary edema in ICU
patients. We propose a study testing the effect of LUS-guided fluid
deresuscitation on duration of invasive ventilation.

Study objective

LUS-guided fluid deresuscitation is superior to standard fluid deresuscitation
without LUS with regard to duration of invasive ventilation

Study design

Multicenter randomized clinical trial

Intervention

LUS-guided fluid deresuscitation; decisions on start and speed of fluid
deresuscitation are guided by LUS findings.

Study burden and risks

minimal, lung ultrasound is a non-invasive and painless investigation

Public
Amsterdam UMC

Meibergdreef 9
Amsterdam 1105 AZ
NL
Scientific
Amsterdam UMC

Meibergdreef 9
Amsterdam 1105 AZ
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- admitted to one of the participating ICUs; and
- expected to be under invasive ventilation for longer than 24 hours

Exclusion criteria

(a) age < 18 years;
(b) pregnancy;
(c) participation in other interventional trials with similar endpoints;
(d) conditions in which LUS cannot be performed or correctly interpreted, i.e.,
chest abnormalities, morbid obesity, and pre-existing interstitial lung
disease,
(e) previous participation in this RCT
(f) patients transferred from another center and invasively ventilated for
longer than than 24 hours

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
1000
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC Academisch Medisch Centrum (Amsterdam)

Kamer G4-214

Postbus 22660

1100 DD Amsterdam

020 566 7389

mecamc@amsterdamumc.nl

Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC Academisch Medisch Centrum (Amsterdam)

Kamer G4-214

Postbus 22660

1100 DD Amsterdam

020 566 7389

mecamc@amsterdamumc.nl

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL76936.018.21