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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Project:

Project ID:PR000924
Project DOI:doi: 10.21228/M8810Q
Project Title:48 hours Post-treatment L-Carnitine Pharmacometabolomics in Sepsis (CaPS) Study
Project Type:Quantitative NMR Metabolomics
Project Summary:To utilize existing serum samples from the phase II clinical trial of L-carnitine treatment for severe sepsis to metabolically phenotype L-carnitine responders and non-responders. Methods: Serum samples collected prior to (T0) and after completion of the infusion (T24, T48) from patients randomized to either low (6 g), intermediate (12g), high (18g) L-carnitine or placebo for the treatment of vasopressor dependent septic shock were assayed by untargeted 1H-nuclear magnetic resonance metabolomics.
Institute:University of Michigan
Laboratory:Stringer NMR Metabolomics Laboratory
Last Name:McHugh
First Name:Cora
Address:428 Church St, Ann Arbor, MI, 48103, USA
Email:NMRmetabolomics@umich.edu
Phone:7343530164
Funding Source:GM111400
Contributors:Michael A. Puskarich, Cora McHugh, Alla Karnovsky, Alan E. Jones, Kathleen A. Stringer

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

Factors:

Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)

mb_sample_id local_sample_id L-carnitine Dose (g)
SA09819122002_T48-
SA09819222001_T48-
SA09819321011_T48-
SA09819422005_T48-
SA09819521014_T48-
SA09819623001_T48-
SA09819750002_T48-
SA09819831003_T48-
SA09819923005_T48-
SA09820021003_T48-
SA09820120015_T48-
SA09820210072_T48-
SA09820310070_T48-
SA09820410068_T48-
SA09820510061_T48-
SA09820610073_T48-
SA09820720006_T48-
SA09820850008_T48-
SA09820920014_T48-
SA09821020007_T48-
SA09821120019_T48-
SA09821250016_T48-
SA098213110009_T48-
SA098214110004_T48-
SA098215110003_T48-
SA098216100005_T48-
SA098217110010_T48-
SA098218110015_T48-
SA098219110027_T48-
SA098220110023_T48-
SA098221110019_T48-
SA09822291007_T48-
SA09822391006_T48-
SA09822450027_T48-
SA09822550022_T48-
SA09822650019_T48-
SA09822770002_T48-
SA09822870011_T48-
SA09822991001_T48-
SA09823080012_T48-
SA09823180010_T48-
SA09823210060_T48-
SA09823330003_T48-
SA09823410006_T48-
SA09823510044_T48-
SA09823610046_T48-
SA09823710036_T48-
SA09823810010_T48-
SA09823910018_T48-
SA09824010015_T48-
SA09824110013_T48-
SA09824210051_T48-
SA09824310009_T48-
SA09824410055_T48-
SA09824510002_T48-
SA09824610057_T48-
SA09826820016_T4812
SA098269110020_T4812
SA09827010005_T4812
SA09827180004_T4812
SA09827250025_T4812
SA09827310012_T4812
SA09827410071_T4812
SA09827550023_T4812
SA09827610003_T4812
SA09827770010_T4812
SA09827820012_T4812
SA098279110002_T4812
SA09828010025_T4812
SA09828121002_T4812
SA09828210020_T4812
SA09828370007_T4812
SA09828421006_T4812
SA09828520025_T4812
SA09828623003_T4812
SA09828721009_T4812
SA09828821007_T4812
SA09828980003_T4812
SA09829023004_T4812
SA09829190004_T4818
SA09829290006_T4818
SA09829380009_T4818
SA09829480006_T4818
SA09829580008_T4818
SA09829680014_T4818
SA09829780005_T4818
SA09829880013_T4818
SA098299110001_T4818
SA098300110013_T4818
SA098301110012_T4818
SA098302110011_T4818
SA09830310008_T4818
SA098304110025_T4818
SA098305110016_T4818
SA098306110024_T4818
SA098307110021_T4818
SA098308110017_T4818
SA098309110008_T4818
SA098310110007_T4818
SA098311100002_T4818
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Collection:

Collection ID:CO001423
Collection Summary:Serum collected via existing intravenous or arterial catheter
Collection Protocol Filename:mchughce_20200409_121816_PR_CO_235.1_NMR_of_CAPS_RACE_Human_Sepsis_Serum.pdf
mchughce_20200409_121816_PR_CO_Expt._235.1_Filtration_of_CaPS_RACE_Serums.pdf
mchughce_20200409_121816_PR_CO_235.01-Serum_MeOH_Precip_and_Resuspension.pdf
Collection Protocol Comments:T0: collected before carnitine or placebo administration, T24: collected 24h after administration of L-carnitine or placebo (±4h), T48: collected 48h after administration of L-carnitine or placebo (±4h)
Sample Type:Blood (serum)
Collection Method:via existing intravenous or arterial catheter
Collection Frequency:1/timepoint, 5 collections/72h
Storage Conditions:-80℃
Collection Vials:SST: Becton-Dickinson 10mL vacutainer Serum Separator tubes
Storage Vials:Sterile 1mL cryovials

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)

Sample Preparation:

Sampleprep ID:SP001436
Sampleprep Summary:Methanol precipitation, ultrafiltration
Sampleprep Protocol ID:Methanol precipitation, Ultrafiltration
Sampleprep Protocol Filename:235.01-Serum_MeOH_Precip_and_Resuspension.pdf
Expt._235.1_Filtration_of_CaPS_RACE_Serums.pdf
Processing Method:Methanol precipitation, dried by lyophilization, ultrafiltered
Processing Storage Conditions:On ice
Extraction Method:Methanol precipitation
Extract Enrichment:Lyophilization
Sample Resuspension:500 uL 50mM sodium phosphate buffer in Deuterium Oxide (D2O)
Sample Spiking:CaFormate internal standard

Analysis:

Analysis ID:AN002253
Laboratory Name:University of Michigan BioNMR core
Analysis Type:NMR
Software Version:VNMRJ 4.0
Operator Name:Jae Hyun Kim, Andrew Benjamin, Thomas Flott
Detector Type:500 MHz
Data Format:.fid
Num Factors:4
Num Metabolites:27
Units:μM

NMR:

NMR ID:NM000163
Analysis ID:AN002253
Instrument Name:Varian 11.74T
Instrument Type:FT-NMR
NMR Experiment Type:1D-1H
NMR Comments:Arrayed for water saturation frequency and 90deg. pulse width for each sample. Varian (now Agilent, Inc., Santa Clara, CA) 11.74 Tesla (500 MHz) NMR spectrometer
Spectrometer Frequency:500 MHz
NMR Probe:5-mm Agilent “One-probe
NMR Solvent:D20
NMR Tube Size:5mm
Shimming Method:Auto shim (gradient shimming)
Pulse Sequence:1 H,1 H-NOESY (commonly referred to as a 1D-NOESY or METNOESY)
Water Suppression:saturation at 80 Hz induced field strength
Pulse Width:~5.5ms, arrayed for in each sample
Temperature:25
Number Of Scans:32
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