Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre randomized controlled trial

Daniel-Mihai Rusu, Ianis Siriopol, Ioana Grigoras, Mihaela Blaj, Adi-Ionut Ciumanghel, Dimitrie Siriopol, Ionut Nistor, Mihai Onofriescu, Gigel Sandu, Beatrice Cobzaru, Dragos Viorel Scripcariu, Olguta Diaconu, Adrian Constantin Covic, Daniel-Mihai Rusu, Ianis Siriopol, Ioana Grigoras, Mihaela Blaj, Adi-Ionut Ciumanghel, Dimitrie Siriopol, Ionut Nistor, Mihai Onofriescu, Gigel Sandu, Beatrice Cobzaru, Dragos Viorel Scripcariu, Olguta Diaconu, Adrian Constantin Covic

Abstract

Background: In routine intensive care unit (ICU) practice, fluids are often administered without a safety limit, which may lead to fluid overload and decreased survival. Recently, B-lines score (BLS) has been validated as a lung ultrasound (LUS) quantification of pulmonary congestion. This suggests that LUS may provide a safety threshold to conduct fluid therapy and to avoid overhydration. However, there is no randomized study to test the utility of LUS in guiding fluid management in ICU patients by using a pre-specified BLS cut-off value as a threshold for fluid removal.

Methods: LUS Guided Fluid Management Protocol for the Critically Ill Patient is a prospective, multi-centre, randomized controlled trial. Five hundred ICU patients will be randomly assigned in a 1:1 ratio, to protocolized LUS-based fluid management or usual care. The trial intervention will start on ICU admission and will consist in daily assessment of BLS and triggered evacuation of excessive fluids with loop diuretics (Furosemide) when BLS ≥ 15. If rebalancing volume status with diuretics fails, forced evacuation by ultrafiltration will be used. The main endpoint is death from all causes at 28 days from randomization. The secondary outcomes are presence and time-course evolution of organ dysfunctions, ICU- and hospital length of stay, all-cause mortality at 90 days, and health economics data.

Discussion: If study results will show that LUS guided fluid management protocol improves outcome in ICU patients, it will be the base for other studies to refine this protocol or track those categories of critically ill patients to whom it may bring maximum benefits.

Trial registration: ClinicalTrials.gov, NCT03393065 . Registered on 8 January 2018.

Keywords: B-lines score; Critically ill patient; Fluid management; Intensive care; Lung ultrasonography; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Research Ethics Committees of the Grigore T. Popa University of Medicine and Pharmacy (date 14 November 2017, number 26261) and by the Research Ethics Committees of the participating hospitals. All patients sign an informed consent.

Consent for publication

All authors consent for publication of the submitted version of this protocol article.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The schedule of study procedures (SPIRIT figure)
Fig. 2
Fig. 2
Algorithm of study protocol

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