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      Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial


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          Sepsis remains a major health challenge with high mortality. Adequate volume administration is fundamental for a successful outcome. However, individual fluid needs differ between patients due to varying degrees of systemic vasodilation, circulatory flow maldistribution, and increased vascular permeability. 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. B lines correlate inversely with oxygenation (measured by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen ie, PaO2/FiO2). Thus, B lines seen by bedside ultrasound may have a role in guiding fluid therapy.


          We aim to evaluate if fluid administration guided by lung ultrasound in patients with sepsis in emergency departments will lead to better oxygenation and patient outcomes than those in the standard therapy.


          A phase II, multicenter, randomized, open-label, parallel-group, superiority trial will be performed. Patients will be recruited at emergency departments of the participating centers. A total of 340 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 (measured as PaO2/FiO2 ratio) at 48 hours after starting intravenous fluid administration. Secondary outcomes will be patients’ outcome parameters, including oxygenation after 15 mL/kg fluid at 6, 12, 24, and 48 hours; sepsis progress through Sequential Organ Failure Assessment (SOFA) scores; pulmonary edema evaluation; and 30-day mortality.


          The trial will be conducted in accordance with the Declaration of Helsinki. Institutional review board approval will be sought after the participating sites are selected. The protocol will be registered once the institutional review board approval is granted. The trial duration is expected to be 1.5-2.5 years. The study is planned to be performed from 2021 to 2022, with enrollment starting in 2021. First results are expected in 2022. Informed written consent will be obtained before the patient’s enrollment in the study. An interim analysis and data monitoring will ensure the patient safety. The results will be published in a peer-reviewed journal and discussed at international conferences.


          This is a protocol for a randomized control trial that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B lines evaluation.

          International Registered Report Identifier (IRRID)


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          Most cited references27

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          NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study.

          Experience with amino-terminal pro-brain natriuretic peptide (NT-proBNP) testing for evaluation of dyspnoeic patients with suspected acute heart failure (HF) is limited to single-centre studies. We wished to establish broader standards for NT-proBNP testing in a study involving four sites in three continents. Differences in NT-proBNP levels among 1256 patients with and without acute HF and the relationship between NT-proBNP levels and HF symptoms were examined. Optimal cut-points for diagnosis and prognosis were identified and verified using bootstrapping and multi-variable logistic regression techniques. Seven hundred and twenty subjects (57.3%) had acute HF, whose median NT-proBNP was considerably higher than those without (4639 vs. 108 pg/mL, P 75, which yielded 90% sensitivity and 84% specificity for acute HF. An age-independent cut-point of 300 pg/mL had 98% negative predictive value to exclude acute HF. Among those with acute HF, a presenting NT-proBNP concentration >5180 pg/mL was strongly predictive of death by 76 days [odds ratio=5.2, 95% confidence interval (CI)=2.2-8.1, P<0.001]. In this multi-centre, international study, NT-proBNP testing was valuable for diagnostic evaluation and short-term prognosis estimation in dyspnoeic subjects with suspected or confirmed acute HF and should establish broader standards for use of the NT-proBNP in dyspnoeic patients.
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            BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill.

            This review article describes two protocols adapted from lung ultrasound: the bedside lung ultrasound in emergency (BLUE)-protocol for the immediate diagnosis of acute respiratory failure and the fluid administration limited by lung sonography (FALLS)-protocol for the management of acute circulatory failure. These applications require the mastery of 10 signs indicating normal lung surface (bat sign, lung sliding, A-lines), pleural effusions (quad and sinusoid sign), lung consolidations (fractal and tissue-like sign), interstitial syndrome (lung rockets), and pneumothorax (stratosphere sign and the lung point). These signs have been assessed in adults, with diagnostic accuracies ranging from 90% to 100%, allowing consideration of ultrasound as a reasonable bedside gold standard. In the BLUE-protocol, profiles have been designed for the main diseases (pneumonia, congestive heart failure, COPD, asthma, pulmonary embolism, pneumothorax), with an accuracy > 90%. In the FALLS-protocol, the change from A-lines to lung rockets appears at a threshold of 18 mm Hg of pulmonary artery occlusion pressure, providing a direct biomarker of clinical volemia. The FALLS-protocol sequentially rules out obstructive, then cardiogenic, then hypovolemic shock for expediting the diagnosis of distributive (usually septic) shock. These applications can be done using simple grayscale machines and one microconvex probe suitable for the whole body. Lung ultrasound is a multifaceted tool also useful for decreasing radiation doses (of interest in neonates where the lung signatures are similar to those in adults), from ARDS to trauma management, and from ICUs to points of care. If done in suitable centers, training is the least of the limitations for making use of this kind of visual medicine.
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              The Surviving Sepsis Campaign Bundle


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                August 2020
                26 August 2020
                : 9
                : 8
                : e15997
                [1 ] Department of General Internal Medicine Hamad Medical Corporation Doha Qatar
                [2 ] Department of Anesthesiology Yale University School of Medicine New Haven, CT United States
                [3 ] Intensive Care Medicine and Pain Management Department of Anaesthesiology Medical Faculty of Ruhr-University Bochum Germany
                [4 ] Department of Physical Medicine and Rehabilitation Spaulding Rehabilitation Hospital and Massachusetts General Hospital Harvard Medical School Boston, MA United States
                [5 ] Graduate School of Biomedical and Health Sciences Hiroshima University Hiroshima Japan
                [6 ] Faculty of Nursing, Suez Canal University Ismailia Egypt
                [7 ] Department of Obstetrics and Gynecology Hamad Medical Corporation Doha Qatar
                [8 ] Radiology Department Santa Casa Belo Horizonte Belo Horizonte Brazil
                [9 ] Division of Oncological Surgery State University of Amazonas Manaus Brazil
                [10 ] Division of Oncological Surgery Getulio Vargas University Hospital Amazonas Brazil
                [11 ] Faculty Of Emergency Medicine Universidad Del Desarrollo-Clinica Alemana De Santiago Santiago Chile
                Author notes
                Corresponding Author: Mouhand F H Mohamed dr.m.oraiby@ 123456hotmail.com
                Author information
                ©Mouhand F H Mohamed, Nathalie M Malewicz, Hanan Ibrahim Zehry, Dina A Monim Hussain, Judah Leão Barouh, Adriana V Cançado, Jeancarllo Sousa Silva, Salah Suwileh, Jose Retamal Carvajal. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.08.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 25 August 2019
                : 27 March 2020
                : 10 April 2020
                : 15 April 2020

                sepsis,fluid resuscitation,pao2/fio2,b-lines,point-of-care ultrasound,pulmonary edema,oxygenation,outcomes,emergency department,ultrasound,lung


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