Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 25, 2019
Date Accepted: Apr 15, 2020
Date Submitted to PubMed: Jul 13, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Protocol for Fluid administration in Emergency Departments limited by Lung Ultrasound (FERLU) in patients with sepsis: a multi-center randomized, controlled, phase II trial.
ABSTRACT
Background:
Sepsis remains a major health challenge with high mortality. Adequate volume administration is fundamental for a successful outcome. But with varying degree of systemic vasodilation, circulatory flow maldistribution and an increase in vascular permeability, the individual fluid need differs between patients. The current fluid resuscitation practice has been questioned. Fluid overload is associated with higher mortality in sepsis. A sign of fluid overload is extravascular lung water, seen as B-lines in lung ultrasound (US). B-lines correlate inversely with oxygenation (PaO2/FiO2). Thus B-lines seen by bedside ultrasound may have a role in guiding fluid therapy.
Objective:
To evaluate if fluid administration guided by lung US in septic patients in Emergency Departments (ED) will lead to better oxygenation and outcomes compared with standard therapy.
Methods:
A multi-center randomized, open-label, parallel group superiority, phase II trial will be performed. Recruitment of patients will occur at admission to the ED. Patients will be randomly allocated to the intervention or standard of care group (30ml/kg). The intervention group will receive ultrasound-guided intravenous fluid until 3 B-lines appear. The primary outcome will be oxygenation at 48 hrs after starting IV fluid administration. Secondary outcomes will be patients’ outcome parameters, including oxygenation, sepsis progress (SOFA), pulmonary edema course after 15ml/kg fluid and at 6, 12, 24, 48 hrs and 30-day mortality. The trial duration is expected to be 1.5-2.5 years.
Results:
The trial will be executed in accordance with the Declaration of Helsinki. Institutional review board (IRB) approval, once the participating sites have been selected, will be sought. Informed written consent will be obtained before the patient’s enrollment in the study. An interim analysis and data monitoring will ensure the patients' safety. The results will be published in a peer reviewed journal and discussed at international conferences.
Conclusions:
This is a protocol for an RCT that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B-Lines evaluation. Clinical Trial: This protocol will be registered once participating sites have been decided and IRB approval granted.
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