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MB Sample ID: SA095469

Local Sample ID:50015_T0
Subject ID:SU001393
Subject Type:Human
Subject Species:Homo sapiens
Taxonomy ID:9606
Age Or Age Range:18-90+
Gender:Male and female
Human Race:White, Black, Asian, Other
Human Inclusion Criteria:Criteria for inclusion were as follows: (1) patients 18 years or older with confirmed or presumed infection; (2) the presence of 2 or more systemic inflammatory response criteria; (3) enrollment within 24 hours of recognition of septic shock with initiation of a standardized sepsis treatment pathway; (4) the use of high-dose vasopressors (norepinephrine bitartrate >0.05 μg/kg/min, dopamine hydrochloride >10 μg/kg/min, phenylephrine hydrochloride >0.4 μg/kg/min, epinephrine >0.05 μg/kg/min, or any vasopressin dose) to treat shock for at least 4 hours at the time of enrollment; (5) cumulative SOFA score of at least 6; (6) and blood lactate level exceeding 18 mg/dL
Human Exclusion Criteria:. Patients were excluded if they were pregnant or breastfeeding or had any of the following characteristics: primary diagnosis other than sepsis, an established do-not-resuscitate status or advance directive restricting aggressive care, any history of seizures, known inborn error of metabolism, anticipated surgery that would interfere with a 12-hour infusion, active participation in another interventional trial, cardiopulmonary resuscitation before enrollment, known allergy to levocarnitine, active warfarin treatment, or severe immunocompromised state

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Treatment:

Treatment ID:TR001408
Treatment Summary:Pharmacists and staff prepared either levocarnitine or placebo in identical polypropylene infusion bags with labels that included the study identification number, patient name, medical record number, and infusion rate. For each dose of levocarnitine, 33% of the total dose was administered as a 20-mL bolus over 2 to 3 minutes, followed by a fixed-rate continuous infusion of 1 L over the next 12 hours. The study solution was administered through intravenous (IV) catheters using US Food and Drug JAMA Network Open | Critical Care Medicine Effect of Levocarnitine vs Placebo as an Adjunctive Treatment for Septic Shock JAMA Network Open. 2018;1(8):e186076. doi:10.1001/jamanetworkopen.2018.6076 (Reprinted) December 21, 2018 3/12 Downloaded From: https://jamanetwork.com/ by a University of Michigan User on 02/07/2020 Administration–approved medical equipment (IV tubing, IV pumps, etc). Levocarnitine was provided by Leadiant Biosciences (formerly Sigma-Tau Pharmaceuticals) and maintained by pharmacy staff, with tracking of lot numbers of levocarnitine administered.
Treatment Compound:). Levocarnitine was provided by Leadiant Biosciences (formerly Sigma-Tau Pharmaceuticals)
Treatment Route:Intravenous
Treatment Dose:0 (0.9% normal saline), 6, 12, 18g
Treatment Doseduration:12h (following initial 33% bolus)
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