Abstract | OBJECTIVES: METHODS: Phase I Bayesian optimal interval design trial of adult patients with septic shock (Sequential Organ Failure Assessment score ≥4 or vasopressor dependence). Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion ( Smoflipid 20% lipid emulsion) within 48 hours of enrollment. Cholesterol levels, function, and organ failure were assessed serially during the first 7 days of hospital admission. MEASUREMENTS AND MAIN RESULTS: A total of 10 patients with septic shock were enrolled. One patient withdrew for social reasons. Another patient had an unrelated medical complication and received 1 drug dose. Of 9 patients, mean age was 58 years (SD 16), median Sequential Organ Failure Assessment was 8, and 28-day mortality was 30%. No serious adverse events related to lipid infusion occurred. The six occurrences of non-serious adverse events possibly related to lipid infusion included hyperglycemia (1), elevated triglycerides (3), anemia (1), and vascular access redness/ pain (1) for all doses. The mean change in total cholesterol levels from enrollment was -7 (SD 16.6) at 48 hours and 14 (SD 25.2) at 7 days. CONCLUSIONS: CLINICAL TRIAL REGISTRATION: NCT03405870.
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Authors | Faheem W Guirgis, Lauren Page Black, Elizabeth DeVos, Morgan Henson, Jason Ferreira, Taylor Miller, Martin Rosenthal, Christiaan Leeuwenburgh, Colleen Kalynych, Lyle Moldawer, Lisa Jones, Marie Crandall, Srinivasa T Reddy, Hanzhi Gao, Sam Wu, Frederick Moore |
Journal | Journal of the American College of Emergency Physicians open
(J Am Coll Emerg Physicians Open)
Vol. 1
Issue 6
Pg. 1332-1340
(Dec 2020)
ISSN: 2688-1152 [Electronic] United States |
PMID | 33392541
(Publication Type: Journal Article)
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Copyright | © 2020 The Authors. JACEP Open published by Wiley Periodicals LLC on behalf of the American College of Emergency Physicians. |