Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial
<h3>Background</h3><p dir="ltr">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, ci...
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2020
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| author | Mouhand F H Mohamed (20318412) |
| author2 | Nathalie M Malewicz (20318415) Hanan Ibrahim Zehry (20318418) Dina A Monim Hussain (20318421) Judah Leão Barouh (8699160) Adriana V Cançado (20318424) Jeancarllo Sousa Silva (20318427) Salah Suwileh (17151034) Jose Retamal Carvajal (20318430) |
| author2_role | author author author author author author author author |
| author_facet | Mouhand F H Mohamed (20318412) Nathalie M Malewicz (20318415) Hanan Ibrahim Zehry (20318418) Dina A Monim Hussain (20318421) Judah Leão Barouh (8699160) Adriana V Cançado (20318424) Jeancarllo Sousa Silva (20318427) Salah Suwileh (17151034) Jose Retamal Carvajal (20318430) |
| author_role | author |
| dc.creator.none.fl_str_mv | Mouhand F H Mohamed (20318412) Nathalie M Malewicz (20318415) Hanan Ibrahim Zehry (20318418) Dina A Monim Hussain (20318421) Judah Leão Barouh (8699160) Adriana V Cançado (20318424) Jeancarllo Sousa Silva (20318427) Salah Suwileh (17151034) Jose Retamal Carvajal (20318430) |
| dc.date.none.fl_str_mv | 2020-08-26T03:00:00Z |
| dc.identifier.none.fl_str_mv | 10.2196/15997 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/journal_contribution/Fluid_Administration_in_Emergency_Room_Limited_by_Lung_Ultrasound_in_Patients_with_Sepsis_Protocol_for_a_Prospective_Phase_II_Multicenter_Randomized_Controlled_Trial/27896283 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Biomedical and clinical sciences Clinical sciences sepsis fluid resuscitation PaO2/FiO2 B-Lines point-of-care ultrasound pulmonary edema oxygenation outcomes emergency department ultrasound lung |
| dc.title.none.fl_str_mv | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| dc.type.none.fl_str_mv | Text Journal contribution info:eu-repo/semantics/publishedVersion text contribution to journal |
| description | <h3>Background</h3><p dir="ltr">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.<br></p><h3>Objective</h3><p dir="ltr">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.<br></p><h3>Methods</h3><p dir="ltr">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.<br></p><h3>Results</h3><p dir="ltr">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.<br></p><h3>Conclusions</h3><p dir="ltr">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.<br></p><p dir="ltr">International Registered Report Identifier (IRRID):PRR1-10.2196/15997<br></p><p dir="ltr">JMIR Res Protoc 2020;9(8):e15997</p><h2>Other Information</h2><p dir="ltr">Published in: JMIR Research Protocols<br>License: <a href="https://creativecommons.org/licenses/by/4.0/" rel="noreferrer" target="_blank">https://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.2196/15997" target="_blank">https://dx.doi.org/10.2196/15997</a></p> |
| eu_rights_str_mv | openAccess |
| id | Manara2_f736e3c9f3f3ee803954d5d3853c1899 |
| identifier_str_mv | 10.2196/15997 |
| network_acronym_str | Manara2 |
| network_name_str | Manara2 |
| oai_identifier_str | oai:figshare.com:article/27896283 |
| publishDate | 2020 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled TrialMouhand F H Mohamed (20318412)Nathalie M Malewicz (20318415)Hanan Ibrahim Zehry (20318418)Dina A Monim Hussain (20318421)Judah Leão Barouh (8699160)Adriana V Cançado (20318424)Jeancarllo Sousa Silva (20318427)Salah Suwileh (17151034)Jose Retamal Carvajal (20318430)Biomedical and clinical sciencesClinical sciencessepsisfluid resuscitationPaO2/FiO2B-Linespoint-of-care ultrasoundpulmonary edemaoxygenationoutcomesemergency departmentultrasoundlung<h3>Background</h3><p dir="ltr">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.<br></p><h3>Objective</h3><p dir="ltr">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.<br></p><h3>Methods</h3><p dir="ltr">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.<br></p><h3>Results</h3><p dir="ltr">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.<br></p><h3>Conclusions</h3><p dir="ltr">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.<br></p><p dir="ltr">International Registered Report Identifier (IRRID):PRR1-10.2196/15997<br></p><p dir="ltr">JMIR Res Protoc 2020;9(8):e15997</p><h2>Other Information</h2><p dir="ltr">Published in: JMIR Research Protocols<br>License: <a href="https://creativecommons.org/licenses/by/4.0/" rel="noreferrer" target="_blank">https://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.2196/15997" target="_blank">https://dx.doi.org/10.2196/15997</a></p>2020-08-26T03:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.2196/15997https://figshare.com/articles/journal_contribution/Fluid_Administration_in_Emergency_Room_Limited_by_Lung_Ultrasound_in_Patients_with_Sepsis_Protocol_for_a_Prospective_Phase_II_Multicenter_Randomized_Controlled_Trial/27896283CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/278962832020-08-26T03:00:00Z |
| spellingShingle | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial Mouhand F H Mohamed (20318412) Biomedical and clinical sciences Clinical sciences sepsis fluid resuscitation PaO2/FiO2 B-Lines point-of-care ultrasound pulmonary edema oxygenation outcomes emergency department ultrasound lung |
| status_str | publishedVersion |
| title | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| title_full | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| title_fullStr | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| title_full_unstemmed | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| title_short | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| title_sort | Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial |
| topic | Biomedical and clinical sciences Clinical sciences sepsis fluid resuscitation PaO2/FiO2 B-Lines point-of-care ultrasound pulmonary edema oxygenation outcomes emergency department ultrasound lung |