Summary of Study ST001354

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR000924. The data can be accessed directly via it's Project DOI: 10.21228/M8810Q This work is supported by NIH grant, U2C- DK119886.

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Study IDST001354
Study Title48 hours post-treatment L-Carnitine Pharmacometabolomics in Sepsis (CaPS) Patients
Study Typemultiple timepoints; patients with severe sepsis or septic shock treated with varying doses of L-carnitine or a saline placebo
Study Summaryphase II study of L-carnitine infusion for the treatment of vasopressor-dependent shock
Institute
University of Michigan
DepartmentClinical Pharmacy
LaboratoryStringer NMR Metabolomics Laboratory
Last NameMcHugh
First NameCora
Address428 Church St, Ann Arbor, MI, 48103, USA
EmailNMRmetabolomics@umich.edu
Phone7343530164
Submit Date2020-04-09
Num Groups4
Total Subjects228
Num Males128
Num Females100
Raw Data AvailableYes
Raw Data File Type(s)fid
Analysis Type DetailNMR
Release Date2020-07-05
Release Version1
Cora McHugh Cora McHugh
https://dx.doi.org/10.21228/M8810Q
ftp://www.metabolomicsworkbench.org/Studies/ application/zip

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Treatment:

Treatment ID:TR001443
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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