Related Experiment Video
Updated: Jan 25, 2026

Bedside Ultrasound for Guiding Fluid Removal in Patients with Pulmonary Edema: The Reverse-FALLS Protocol
Published on: July 28, 2018
Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre
Daniel-Mihai Rusu1,2, Ianis Siriopol1,2, Ioana Grigoras3,4
1Grigore T. Popa University of Medicine and Pharmacy, Str. Universității nr. 16, 700115, Iasi, Romania.
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.
Related Concept Videos
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Trial and Error and Algorithm
Critical Region, Critical Values and Significance Level
In hypothesis testing, a sample statistic is converted to a test statistic using z, t, or chi-square distribution. A critical region is an area under the curve in probability distributions demarcated by the critical value. When the test statistic falls in this region, it suggests that the null hypothesis must be rejected. As this region contains all those values of the...

