Summary of Study ST001319

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 PR000896. The data can be accessed directly via it's Project DOI: 10.21228/M8VX0Z This work is supported by NIH grant, U2C- DK119886.

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Study IDST001319
Study TitlePre-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
LaboratoryStringer NMR Metabolomics Laboratory
Last NameMcHugh
First NameCora
Address428 Church St, Ann Arbor, MI, 48103, USA
EmailNMRmetabolomics@umich.edu
Phone7343530164
Submit Date2020-02-07
Num Groups4
Total Subjects228
Num Males128
Num Females100
PublicationsThis submission is Phase II: https://www.ncbi.nlm.nih.gov/pubmed/30646314 doi: 10.1001/jamanetworkopen.2018.6076 Earlier Phase I: Metabolomics Workbench: doi: 10.21228/M8VM2M https://www.ncbi.nlm.nih.gov/pubmed/23851424 doi: 10.1177/0148607113495414
Raw Data AvailableYes
Raw Data File Type(s)fid
Analysis Type DetailNMR
Release Date2020-09-10
Release Version1
Cora McHugh Cora McHugh
https://dx.doi.org/10.21228/M8VX0Z
ftp://www.metabolomicsworkbench.org/Studies/ application/zip

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Subject:

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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