Summary of Study ST001354

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench,, 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
University of Michigan
DepartmentClinical Pharmacy
LaboratoryStringer NMR Metabolomics Laboratory
Last NameMcHugh
First NameCora
Address428 Church St, Ann Arbor, MI, 48103, USA
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 application/zip

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Subject ID:SU001428
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