Welcome to the CONFIDENCE study page

The effect of lung ultrasound guided fluid deresuscitation on duration of ventilation in Intensive Care Unit patients (CONFIDENCE) study is a multicenter RCT. On this webpage you can find study information for participating researchers and interested parties.

NEWS

15 januari 2024

400 patients included in the CONFIDENCE trial!

400 patients have now been included in the trial!

9 augustus 2023

200 CONFIDENCE patients included

200 patients have been included in the CONFIDENCE trial! With the start of new centers, inclusion rate is increasing rapidly.

10 mei 2023

Publication of the CONFIDENCE trial protocol

The trial protocol has been published with open access in BioMedCentral Trials.

10 mei 2023

100 CONFIDENCE patients included

The hundredth patient was included in the trial!

Currently recruiting centers

  • 12 centers in the Netherlands are currently operational

 

Participants included

  • 400 patients in Januari 2024

Study Summary

Rationale

Fluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer invasive ventilation and length of intensive care unit (ICU) stay. However, optimal timing and rate of deresuscitation remain unclear. Lung ultrasound (LUS) may be used to identify fluid overload. We hypothesis that daily LUS-guided deresuscitation is superior to deresuscitation without LUS in critically ill patients expected to undergo invasive ventilation for more than 24 h in terms of ventilator free-days and being alive at day 28.

Objective

The aim of this study is to determine if deresuscitation guided by LUS leads to an increase in ventilator-free days and alive at day 28, a composite endpoint of duration of ventilation and mortality, compared to deresuscitation without LUS guidance.

Study design

The CONFIDENCE study is an national, investigator-initiated multicenter randomized clinical trial (RCT).

Study population

This study will include 1000 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with an expected duration of ventilation of >24 hours.

Intervention

LUS examinations are performed at least once a day when the patient is hemodynamically stable. LUS examination can lead to three possible results and corresponding treatment:

(1) LUS suggests substantial pulmonary edema. We recommend the clinician to target a negative fluid balance of at least − 1500 ml in the next 24 h.

(2) LUS suggests some pulmonary edema and/or significant pleural effusion. We recommend the clinician to target a negative fluid balance of at least − 500 ml in the next 24 h.

(3) LUS suggests no pulmonary edema and no pleural effusion. We recommend the clinician to target a neutral fluid balance in the next 24 h.

Subject allocated to the usual care arm will be deresuscitated at the discretion of the treating physician

Main study parameters/endpoints

The primary endpoint is the number of ventilator-free days and being alive at day 28. Secondary endpoints include the duration of invasive ventilation; mortality; length of stay; cumulative fluid balance on days 1–7 after randomization and on days 1–7 after start of LUS examination; mean serum lactate on days 1–7; the incidence of reintubations, chest drain placement, atrial fibrillation, kidney injury (KDIGO stadium ≥ 2) and hypernatremia; the use of invasive hemodynamic monitoring, and chest-X-ray; and quality of life at day 28.

Documents

Study team

Participating researchers

Erasmus MC, Rotterdam, The Netherlands:

  • Henrik Endeman
  • Leo Heunks

Rijnstate Hospital, Arnhem, The Netherlands:

  • Michiel Blans
  • Aart Strang

Spaarne Gasthuis, Haarlem & Hoofddorp, The Netherlands:

  • Sylvia den Boer
  • Jolanda van den Dool
  • Johan Weenink

Zuyderland Medical Centre, Heerlen & Geleen, The Netherlands:

  • Laura Bormans-Russell
  • Tom Dormans

Amstelland Hospital, Amstelveen, The Netherlands:

  • Timo Roeleveld

Catharina Hospital, Eindhoven, The Netherlands:

  • Ashley de Bie
  • Harm Scholten

TerGooi MC, Hilversum, The Netherlands:

  • Eline van Slobbe-Bijlsma
  • Roel Vink

Adrz, Goes, The Netherlands:

  • Laura Cox

St. Antonius Hospital, Nieuwegein, The Netherlands:

  • Mart de Graaff
  • Erik Scholten

Radboud University Medical Centre, Nijmegen, The Netherlands:

  • Hugo Touw

Rode Kruis Hospital, Beverwijk, The Netherlands:

  • Fleur van der Ven
  • Evelien de Jong
  • Stephan Papendorp

Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands:

  • Evert-Jan Wils

Reinier de Graaf Hospital, Delft, The Netherlands:

  • Louise Urlings

Gelre Hospital, Apeldoorn, The Netherlands:

  • Marnix Kuindersma

Noordwest Hospital, Alkmaar, The Netherlands:

  • Liz Bruin
  • Stefanie Slot

Leiden University Medical Centre, Leiden, The Netherlands:

  • Carlos Elzo Kraemer
  • Jorge Lopez Matta
  • Michael del Prado
  • David J. van Westerloo
  • Jeanette Wigbers

Data and Safety Monitoring Board

Prof. Frank van Haren, Chair of the DSMB

St, George Hospital, Sydney, Australia.

Dr. Oriol Roca

Corporació Sanitària Parc Taulí, Sabadell, Spain

Prof. Arjen Dondorp

Mahidol-Oxford Clinical Research Unit, Bangkok, Thailand

Dr. Ary Serpa Neto, Independent statistician

Australian and New Zealand Intensive Care-Research Centre (ANZIC-RC), Melbourne, Australia

Dr. Louise Thwaites

Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam

 

 

The Data Safety Monitoring Board has had 3 meetings as of Januari 2024. No concerns regarding safety or data quality were raised.

eCRF

The eCRF is built in Castor EDC, a program that can be reached from everywhere via the internet. Randomization and reporting of protocol deviations will also be performed in this system.

Trial registration

Registration of the CONFIDENCE study at clinicaltrials.gov.

Contact

Questions or interested in CONFIDENCE? Please contact us.

Formulier Afbeelding