{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T06:04:48Z","timestamp":1789452288644,"version":"build-2803163510"},"reference-count":54,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T00:00:00Z","timestamp":1789430400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Traumatic brain injury (TBI) is associated with substantial mortality and long-term disability worldwide. Acute respiratory distress syndrome (ARDS), as a common complication in moderate-to-severe TBI, further aggravates clinical outcomes and resource utilization. However, effective interventions to prevent TBI-associated ARDS remain limited. This trial aims to evaluate whether early intravenous magnesium sulfate reduces the risk of ARDS and improves clinical outcomes in patients with moderate-to-severe TBI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This protocol outlines a randomized, controlled, double-blind clinical trial involving 164 adults (18\u201375 years) with moderate-to-severe TBI (Glasgow Coma Scale [GCS] 3\u201312) within 8\u2005h of injury. Participants will be stratified by baseline GCS (3\u20138 vs. 9\u201312) and randomized 1:1 to the intravenous magnesium sulfate group (initial 2\u2005g over 30\u2005min within 8\u2005h, then 2\u2005g daily for 5 days; total 12\u2005g) or an identical placebo group. Both groups will receive guideline-directed standard TBI care. The primary endpoint is a 28-day hierarchical composite (all-cause mortality, then new-onset ARDS within days 1\u20137, then\u2009\u2264\u200920% increase in PaO\u2082\/FiO\u2082 AUC from baseline over days 0\u20135). The hierarchical composite primary endpoint will be analyzed using the win-ratio method. Secondary outcomes include ICU and hospital length of stay, complications, and serial biomarker changes. Follow-up assessments will be conducted on day 28 and at 6 months post-treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>If effective, this low-cost intervention could be readily incorporated into standard TBI care and help prevent TBI-associated ARDS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>Chinese Clinical Trial Registry, identifier ChiCTR2600120684.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1900332","type":"journal-article","created":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T05:36:38Z","timestamp":1789450598000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of early intravenous magnesium sulfate on clinical outcomes in patients with moderate to severe traumatic brain injury: a study protocol for a randomized controlled trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Hong","family":"Xi","sequence":"first","affiliation":[{"name":"Department of Anesthesiology, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital","place":["Taiyuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifan","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University","place":["Taiyuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lixiong","family":"Xue","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University","place":["Taiyuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiang","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University","place":["Taiyuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University","place":["Taiyuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hailong","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical 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