{
"METABOLOMICS WORKBENCH":{"STUDY_ID":"ST000785","ANALYSIS_ID":"AN001244","VERSION":"1","CREATED_ON":"July 6, 2017, 2:31 pm"},

"PROJECT":{"PROJECT_TITLE":"Pharmacometabolomics of L-Carnitine Treatment for Septic Shock","PROJECT_TYPE":"Quantitative NMR Metabolomics","PROJECT_SUMMARY":"Rationale: Sepsis therapeutics have a poor history of success in clinical trials, due in part to the heterogeneity of enrolled patients. Pharmacometabolomics could differentiate drug response phenotypes and permit a precision medicine approach to sepsis. Objective: To utilize existing serum samples from the phase I 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 L-carnitine (12 g) or placebo for the treatment of vasopressor dependent septic shock were assayed by untargeted 1H-nuclear magnetic resonance metabolomics. The normalized, quantified metabolite data sets of L-carnitine and placebo treated patients at each time point were compared by ANOVA with post-hoc testing for multiple comparisons. Pathway analysis was performed to statistically rank metabolic networks. Measurements and main results: 38 metabolites were identified in all samples. Concentrations of 3-hydroxybutyrate, acetoacetate, 3-hydroxyisovalerate were different at T0 and over time in L-carnitine treated survivors versus non-survivors. Pathway analysis of pre-treatment metabolites revealed that synthesis and degradation of ketone bodies had the greatest impact in differentiating L-carnitine treatment response. Analysis of all patients based on pre-treatment 3-hydroxybutyrate concentration yielded distinct phenotypes. Using the T0 median 3-hydroxybutyrate level (153µM), patients were categorized as either high or low ketone. L-carnitine treated low ketone patients had greater utilization of carnitine as evidenced by lower post-treatment L-carnitine levels. The L-carnitine responders also had faster resolution of vasopressor requirement and a trend towards a greater improvement in mortality at 1 year (p = 0.038) compared with patients with higher 3-hydroxybutyrate. Conclusions: The results of this preliminary study, that were not readily apparent from the parent clinical trial, show a unique metabolite profile of L-carnitine responders and introduce pharmacometabolomics as a viable strategy for informing L-carnitine responsiveness. The approach taken in this study represents a concrete example for the application of precision medicine to sepsis therapeutics that warrants further study. This study was published: Ann Am Thorac Soc 2015;12:46-56.","INSTITUTE":"University of Michigan","DEPARTMENT":"Clinical Pharmacy; Center for Bioinformatics and Computational medicine (UMich); Emergency Medicine (UMiss)","LABORATORY":"University of Michigan NMR Metabolomics Laboratory","LAST_NAME":"Kathleen","FIRST_NAME":"Stringer","ADDRESS":"College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109","EMAIL":"stringek@umich.edu","PHONE":"none","FUNDING_SOURCE":"This study was supported by the University of Michigan’s College of Pharmacy and its Biochemical Nuclear Magnetic Resonance Core and in part by the Michigan Regional Comprehensive Metabolomics Research Core (AK and Chenomx software), which is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK; DK097153). The clinical trial was supported by a grant from the American Heart Association (10POST3560001) and the Cannon Foundation (SRG10-004). Dr. Jones’ effort was supported by a grant from the National Institute of General Medicine (NIGMS; R01GM103799). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIDDK, NIGMS or the National Institutes of Health. NIDDK (DK097153)."},

"STUDY":{"STUDY_TITLE":"Pharmacometabolomics of L-Carnitine Treatment Response Phenotypes in Patients with Septic Shock","STUDY_TYPE":"multiple timepoints; patients with severe sepsis or septic shock","STUDY_SUMMARY":"phase I study of L-carnitine infusion for the treatment of vasopressor-dependent shock","INSTITUTE":"University of Michigan","DEPARTMENT":"Clinical Pharmacy","LABORATORY":"The NMR Metabolomics Laboratory (Stringer)","LAST_NAME":"Stringer","FIRST_NAME":"Kathleen","ADDRESS":"University Michigan, 2900 Huron Parkway, Ann Arbor, MI 48105","EMAIL":"stringek@umich.edu","PHONE":"none","NUM_GROUPS":"2","TOTAL_SUBJECTS":"31"},

"SUBJECT":{"SUBJECT_TYPE":"Human","SUBJECT_SPECIES":"Homo sapiens","TAXONOMY_ID":"9606","AGE_OR_AGE_RANGE":"39-93 years","WEIGHT_OR_WEIGHT_RANGE":"55-130 KG","GENDER":"males and females","HUMAN_RACE":"Caucasian (C) and African American (AA)","HUMAN_INCLUSION_CRITERIA":"Suspicion of or confirmed infection; two or more systemic infmammatory response syndrome criteria; hypotension requiring vasopressors despite volume resuscitation; a cumulative vasopressor index of 3 or more after 4 hours of administration; and a SOFA score of at least 5.","HUMAN_EXCLUSION_CRITERIA":"Age less than 18; greater than 16h after septic shock recognition; a Do Not Resuscitate order; or known inborn error of metaboloism."},
"SUBJECT_SAMPLE_FACTORS":[
{
"Subject ID":"CMC2001",
"Sample ID":"CMC2001-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2001",
"Sample ID":"CMC2001-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2001",
"Sample ID":"CMC2001-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2002",
"Sample ID":"CMC2002-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2002",
"Sample ID":"CMC2002-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2002",
"Sample ID":"CMC2002-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2003",
"Sample ID":"CMC2003-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2003",
"Sample ID":"CMC2003-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2003",
"Sample ID":"CMC2003-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2004",
"Sample ID":"CMC2004-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2004",
"Sample ID":"CMC2004-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2004",
"Sample ID":"CMC2004-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2005",
"Sample ID":"CMC2005-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2005",
"Sample ID":"CMC2005-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2005",
"Sample ID":"CMC2005-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2006",
"Sample ID":"CMC2006-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2006",
"Sample ID":"CMC2006-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2006",
"Sample ID":"CMC2006-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2007",
"Sample ID":"CMC2007-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2007",
"Sample ID":"CMC2007-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2007",
"Sample ID":"CMC2007-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2008",
"Sample ID":"CMC2008-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2008",
"Sample ID":"CMC2008-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2008",
"Sample ID":"CMC2008-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2009",
"Sample ID":"CMC2009-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2009",
"Sample ID":"CMC2009-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2009",
"Sample ID":"CMC2009-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2010",
"Sample ID":"CMC2010-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2011",
"Sample ID":"CMC2011-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2012",
"Sample ID":"CMC2012-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2012",
"Sample ID":"CMC2012-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2012",
"Sample ID":"CMC2012-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2013",
"Sample ID":"CMC2013-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2013",
"Sample ID":"CMC2013-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2013",
"Sample ID":"CMC2013-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2014",
"Sample ID":"CMC2014-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2014",
"Sample ID":"CMC2014-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2014",
"Sample ID":"CMC2014-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2015",
"Sample ID":"CMC2015-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2015",
"Sample ID":"CMC2015-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2015",
"Sample ID":"CMC2015-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2016",
"Sample ID":"CMC2016-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2016",
"Sample ID":"CMC2016-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2016",
"Sample ID":"CMC2016-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2017",
"Sample ID":"CMC2017-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2017",
"Sample ID":"CMC2017-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2017",
"Sample ID":"CMC2017-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2018",
"Sample ID":"CMC2018-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2019",
"Sample ID":"CMC2019-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2019",
"Sample ID":"CMC2019-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2019",
"Sample ID":"CMC2019-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2020",
"Sample ID":"CMC2020-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2020",
"Sample ID":"CMC2020-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2020",
"Sample ID":"CMC2020-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2021",
"Sample ID":"CMC2021-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2021",
"Sample ID":"CMC2021-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2022",
"Sample ID":"CMC2022-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2023",
"Sample ID":"CMC2023-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2023",
"Sample ID":"CMC2023-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2023",
"Sample ID":"CMC2023-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2024",
"Sample ID":"CMC2024-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2024",
"Sample ID":"CMC2024-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2024",
"Sample ID":"CMC2024-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2025",
"Sample ID":"CMC2025-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2025",
"Sample ID":"CMC2025-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2025",
"Sample ID":"CMC2025-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2026",
"Sample ID":"CMC2026-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2026",
"Sample ID":"CMC2026-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2026",
"Sample ID":"CMC2026-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2027",
"Sample ID":"CMC2027-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2027",
"Sample ID":"CMC2027-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2027",
"Sample ID":"CMC2027-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2028",
"Sample ID":"CMC2028-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2028",
"Sample ID":"CMC2028-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2029",
"Sample ID":"CMC2029-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2029",
"Sample ID":"CMC2029-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2029",
"Sample ID":"CMC2029-48",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2030",
"Sample ID":"CMC2030-0",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2030",
"Sample ID":"CMC2030-24",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2030",
"Sample ID":"CMC2030-48",
"Factors":{"Treatment":"Placebo"}
},
{
"Subject ID":"CMC2031",
"Sample ID":"CMC2031-0",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2031",
"Sample ID":"CMC2031-24",
"Factors":{"Treatment":"Carnitine"}
},
{
"Subject ID":"CMC2031",
"Sample ID":"CMC2031-48",
"Factors":{"Treatment":"Carnitine"}
}
],
"COLLECTION":{"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, 3 collections/48h","COLLECTION_TIME":"T0: before administration, T24: 24h after administration (±4h), T48: 48h after administration (±4h)","VOLUMEORAMOUNT_COLLECTED":"10mL","STORAGE_CONDITIONS":"Initial RT then -80°C following processing (within 2h of collection)","COLLECTION_VIALS":"SST: Becton-Dickinson 10mL vacutainer Serum Separator tubes","STORAGE_VIALS":"Sterile 1mL cryovials","COLLECTION_TUBE_TEMP":"RT","ADDITIVES":"None","BLOOD_SERUM_OR_PLASMA":"Serum"},

"TREATMENT":{"TREATMENT_SUMMARY":"Intravenous carnitine","TREATMENT_PROTOCOL_COMMENTS":"Non-treatment group: equivalent volume of saline placebo","TREATMENT_COMPOUND":"L-carnitine","TREATMENT_ROUTE":"4g bolus followed by an 8g infusion over 12h","TREATMENT_DOSE":"12g","TREATMENT_DOSEDURATION":"12h (following initial 4g bolus)"},

"SAMPLEPREP":{"SAMPLEPREP_SUMMARY":"Methanol:cholorform extraction, filtration","SAMPLEPREP_PROTOCOL_COMMENTS":"Lipid fractions saved, stored at -20°C","PROCESSING_METHOD":"Methanol:Chloroform Extraction, filtration","PROCESSING_STORAGE_CONDITIONS":"0-4°C","EXTRACTION_METHOD":"Methanol:chloroform extraction","EXTRACT_ENRICHMENT":"Ultra-filtration (3kDa filters) to remove residual protein","EXTRACT_CLEANUP":"N/A","EXTRACT_STORAGE":"-80 C","SAMPLE_RESUSPENSION":"=500 uL Deuterium Oxide (D2O)","SAMPLE_SPIKING":"CaFormate 12mM"},

"CHROMATOGRAPHY":{"CHROMATOGRAPHY_TYPE":"-","INSTRUMENT_NAME":"-","COLUMN_NAME":"-"},

"ANALYSIS":{"ANALYSIS_TYPE":"NMR"},

"NM":{"INSTRUMENT_NAME":"Agilent 500/54 Premium Shielded VNMRS system","INSTRUMENT_TYPE":"FT-NMR","NMR_EXPERIMENT_TYPE":"1D-1H","NMR_COMMENTS":"Experiment dates: 11/7/2013, 11/11/2013, 11/19/2013","STANDARD_CONCENTRATION":"10% (~0.5mM)","SPECTROMETER_FREQUENCY":"500 MHz","NMR_PROBE":"ONE-Probe","NMR_SOLVENT":"D2O","NMR_TUBE_SIZE":"5mm","SHIMMING_METHOD":"Auto shim (gradient shimming)","PULSE_SEQUENCE":"1D-NOESY","WATER_SUPPRESSION":"saturation at 80 Hz induced field strength","PULSE_WIDTH":"5.5ms","POWER_LEVEL":"around -178Hz","CHEMICAL_SHIFT_REF_CPD":"Formate","TEMPERATURE":"25°C","NUMBER_OF_SCANS":"32","BASELINE_CORRECTION_METHOD":"manual","CHEMICAL_SHIFT_REF_STD":"Calcium Formate"},

"NMR_METABOLITE_DATA":{
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