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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Project:

Project ID:PR000896
Project DOI:doi: 10.21228/M8VX0Z
Project Title:Pre-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:Kathleen Stringer, Mike Puskarich, Alan Jones

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

Factors:

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

mb_sample_id local_sample_id L-carnitine Dose (g) Sex
SA09533170007_T012 Female
SA09533250023_T012 Female
SA09533380004_T012 Female
SA09533421002_T012 Female
SA095335100003_T012 Female
SA095336110002_T012 Female
SA095337110020_T012 Female
SA09533820002_T012 Female
SA09533910025_T012 Female
SA09534010020_T012 Female
SA09534110005_T012 Female
SA09534231001_T012 Male
SA09534310003_T012 Male
SA09534421009_T012 Male
SA09534521007_T012 Male
SA09534623003_T012 Male
SA09534750025_T012 Male
SA09534880003_T012 Male
SA09534910014_T012 Male
SA09535021006_T012 Male
SA09535170010_T012 Male
SA09535250003_T012 Male
SA09535310012_T012 Male
SA09535423004_T012 Male
SA09535520018_T012 Male
SA09535620016_T012 Male
SA09535710071_T012 Male
SA09535820025_T012 Male
SA09535920012_T012 Male
SA15236980002_T012 Male
SA15237080011_T012 Male
SA09536010030_T018 Female
SA09536110033_T018 Female
SA09536220017_T018 Female
SA09536310026_T018 Female
SA09536410024_T018 Female
SA09536580013_T018 Female
SA09536610065_T018 Female
SA09536750006_T018 Female
SA09536810027_T018 Female
SA09536910054_T018 Female
SA09537050011_T018 Female
SA09537120013_T018 Female
SA095372110026_T018 Female
SA09537320010_T018 Female
SA09537410004_T018 Female
SA095375110025_T018 Female
SA09537610069_T018 Female
SA09537780008_T018 Female
SA09537810035_T018 Female
SA09537980005_T018 Female
SA09538010017_T018 Female
SA09538150007_T018 Female
SA09538231007_T018 Female
SA095383110005_T018 Female
SA09538410043_T018 Female
SA09538510042_T018 Female
SA09538690009_T018 Female
SA09538710047_T018 Female
SA09538821012_T018 Female
SA09538921004_T018 Female
SA09539010059_T018 Female
SA09539191003_T018 Female
SA09539210040_T018 Female
SA09539310045_T018 Female
SA095394110016_T018 Female
SA09539530002_T018 Female
SA095396100002_T018 Female
SA095397110007_T018 Female
SA09539890007_T018 Female
SA15236770001_T018 Female
SA09539991005_T018 Male
SA09540090004_T018 Male
SA095401110008_T018 Male
SA095402110001_T018 Male
SA09540370009_T018 Male
SA095404110011_T018 Male
SA09540570008_T018 Male
SA09540691004_T018 Male
SA095407100004_T018 Male
SA09540880017_T018 Male
SA095409110017_T018 Male
SA09541080009_T018 Male
SA095411110021_T018 Male
SA09541280014_T018 Male
SA095413110013_T018 Male
SA09541480006_T018 Male
SA095415110012_T018 Male
SA095416110024_T018 Male
SA09541791002_T018 Male
SA09541890006_T018 Male
SA09541923002_T018 Male
SA09542010063_T018 Male
SA09542110066_T018 Male
SA09542210062_T018 Male
SA09542310058_T018 Male
SA09542410053_T018 Male
SA09542510067_T018 Male
SA09542620001_T018 Male
SA09542721008_T018 Male
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Collection:

Collection ID:CO001388
Collection Summary:Serum collected via existing intravenous or arterial catheter
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:TR001408
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:SP001401
Sampleprep Summary:Methanol precipitation, ultrafiltration
Sampleprep Protocol ID:Methanol precipitation, Ultrafiltration
Sampleprep Protocol Filename:235.01-Serum_MeOH_Precip_and_Resuspension, Expt._235.1_Filtration_of_CaPS_RACE_Serums
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:AN002195
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:8
Num Metabolites:27
Units:μM

NMR:

NMR ID:NM000161
Analysis ID:AN002195
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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