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.
See: https://www.metabolomicsworkbench.org/about/howtocite.php
| Study ID | ST001354 |
| Study Title | 48 hours post-treatment L-Carnitine Pharmacometabolomics in Sepsis (CaPS) Patients |
| Study Type | multiple timepoints; patients with severe sepsis or septic shock treated with varying doses of L-carnitine or a saline placebo |
| Study Summary | phase II study of L-carnitine infusion for the treatment of vasopressor-dependent shock |
| Institute | University of Michigan |
| Department | Clinical Pharmacy |
| Laboratory | Stringer NMR Metabolomics Laboratory |
| Last Name | McHugh |
| First Name | Cora |
| Address | 428 Church St, Ann Arbor, MI, 48103, USA |
| NMRmetabolomics@umich.edu | |
| Phone | 7343530164 |
| Submit Date | 2020-04-09 |
| Num Groups | 4 |
| Total Subjects | 228 |
| Num Males | 128 |
| Num Females | 100 |
| Raw Data Available | Yes |
| Raw Data File Type(s) | fid |
| Analysis Type Detail | NMR |
| Release Date | 2020-07-05 |
| Release Version | 1 |
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Subject:
| 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 |
| Species Group: | Mammals |
