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MB Sample ID: SA095407
| Local Sample ID: | 100004_T0 |
| 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 |
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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:
| Local Sample ID | MB Sample ID | Factor Level ID | Level Value | Factor Name |
|---|---|---|---|---|
| 100004_T0 | SA095407 | FL013549 | 18 | L-carnitine Dose (g) |
| 100004_T0 | SA095407 | FL013549 | Male | Sex |
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:
| MB Sample ID: | SA095407 |
| 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 |
