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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.

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