{"id":24415,"date":"2023-08-22T04:14:00","date_gmt":"2023-08-21T20:14:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=24415"},"modified":"2023-08-22T05:48:05","modified_gmt":"2023-08-21T21:48:05","slug":"chest%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e9%9d%99%e8%84%89%e5%a4%a7%e5%89%82%e9%87%8f%e7%bb%b4%e7%94%9f%e7%b4%a0b12%e6%b2%bb%e7%96%97%e6%84%9f%e6%9f%93%e6%80%a7%e4%bc%91%e5%85%8b","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=24415","title":{"rendered":"[Chest\u53d1\u8868\u8bba\u6587]\uff1a\u9759\u8109\u5927\u5242\u91cf\u7ef4\u751f\u7d20B12\u6cbb\u7597\u611f\u67d3\u6027\u4f11\u514b"},"content":{"rendered":"\n

CRITICAL CARE: ORIGINAL RESEARCH|\u00a0VOLUME 163, ISSUE 2<\/a>,\u00a0P303-312,\u00a0FEBRUARY 2023Download Full Issue<\/p>\n\n\n\n

High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial)<\/h1>\n\n\n\n

Jayshil J. Patel, Rodney Willoughby, Jennifer Peterson, et al<\/h3>\n\n\n\n

Chest 2023; 163: 303-312 Published:September 26, 2022<\/h3>\n\n\n\n

DOI:https:\/\/doi.org\/10.1016\/j.chest.2022.09.021<\/a><\/h3>\n\n\n\n

Background<\/h3>\n\n\n\n

Elevated hydrogen sulfide (H2<\/sub>S) contributes to vasodilatation and hypotension in septic shock, and traditional therapies do not target this pathophysiologic mechanism. High-dose IV hydroxocobalamin scavenges and prevents H2<\/sub>S formation, which may restore vascular tone and may accentuate recovery. No experimental human studies have tested high-dose IV hydroxocobalamin in adults with septic shock.<\/p>\n\n\n\n

Research Question<\/h3>\n\n\n\n

In adults with septic shock, is comparing high-dose IV hydroxocobalamin with placebo feasible?<\/p>\n\n\n\n

Study Design and Methods<\/h3>\n\n\n\n

We conducted a phase 2 single-center, double-blind, allocation-concealed, placebo-controlled, parallel-group pilot randomized controlled trial comparing high-dose IV hydroxocobalamin with placebo in critically ill adults with septic shock. Patients meeting Sepsis 3 criteria were randomized 1:1 to receive a single 5-g dose of high-dose IV hydroxocobalamin or equivalent volume 0.9% saline solution as placebo. The primary outcome was study feasibility (enrollment rate, clinical and laboratory compliance rate, and contamination rate). Secondary outcomes included between-group differences in plasma H2<\/sub>S concentrations and vasopressor dose before and after infusion.<\/p>\n\n\n\n

Results<\/h3>\n\n\n\n

Twenty patients were enrolled over 19\u00a0months, establishing an enrollment rate of 1.05 patients per month. Protocol adherence rates were 100%\u00a0with zero contamination. In the high-dose IV hydroxocobalamin group, compared to placebo, there was a greater reduction in vasopressor dose between randomization and postinfusion (-36%\u00a0vs\u00a04%, P\u00a0< .001) and randomization and 3-h postinfusion (-28%\u00a0vs\u00a010%, P\u00a0= .019). In the high-dose IV hydroxocobalamin group, the plasma H2<\/sub>S level was reduced over 45 mins by \u20130.80 \u00b1 1.73 \u03bcM, as compared with \u20130.21 \u00b1 0.64 \u03bcM in the placebo group (P<\/em>\u00a0= .3).<\/p>\n\n\n\n

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Interpretation<\/h3>\n\n\n\n

This pilot trial established favorable feasibility metrics. Consistent with the proposed mechanism of benefit, high-dose IV hydroxocobalamin compared with placebo was associated with reduced vasopressor dose and H2<\/sub>S levels at all time points and without serious adverse events. These data provide the first proof of concept for feasibility of delivering high-dose IV hydroxocobalamin in septic shock.<\/p>\n\n\n\n

Trial Registry<\/h3>\n\n\n\n

ClinicalTrials.gov; No.: NCT03783091; URL: www.clinicaltrials.gov<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

CRITICAL CARE: ORIGINAL RESEARCH|\u00a0VOLUME 163, ISSUE 2,\u00a0 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24415"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=24415"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24415\/revisions"}],"predecessor-version":[{"id":24416,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24415\/revisions\/24416"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24415"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24415"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24415"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}