Intravenous Vitamin C. Severe Sepsis Acute Lung Injury
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1 Intravenous Vitamin C Severe Sepsis Acute Lung Injury Alpha A. (Berry) Fowler, III, MD Professor of Medicine VCU Pulmonary Disease and Critical Care Medicine
2 I Have No Disclosures
3 Bacterial Sepsis Approximately 1 million people in the U.S. develop sepsis each year 35% to 40% of septic patients develop Acute lung injury 25% to 35% of septic lung-injured patients die
4 832 Passengers 1 Fully Loaded Boeing Passengers Muhammad Patty Duke Ali Sepsis Abdominal - Pneumonia Sepsis March June 29 3, 2016
5 Vitamin C in Disease Normal Plasma Vitamin C Level Trauma Sepsis
6 Surgical Sepsis Surgical Sepsis Vitamin C 20 Hours 20 Hours Detailed Study of Lung Tissue Detailed Study of Lung Tissue
7 Septic Murine Lung Vitamin C Treated Septic Lung
8 Vitamin C Attenuates Histological Evidence Of Lung Injury Surgical Sepsis Surgical Sepsis Vitamin C Treated
9 Lung Water Control Sepsis Sepsis VC
10 Plasma Ascorbate Levels In Human Sepsis Subnormal levels a constant feature in septic patients Ascorbate levels correlate inversely with the incidence of multiple organ failure (low levels higher numbers of organs failed) Ascorbate levels correlate directly with survival (low levels low survival) Borrelli et al. Crit Care Med. 1996, 24 (3): , PMID:
11 Phase I Safety Trial Severe Sepsis IRB (April 2010) Enrollment (August 2010) Septic Patients: Geographic MRICU patients Randomized, double blind, placebo-controlled AE: Systemic hypotension, tachycardia, nausea 1) Placebo, 2) 50 mg/kg/24 hr, 3) 200 mg/kg/24 hr IV VitC ¼ dose infused 6 hours D5%W Blood Draw (0, 12, 24, 36, 48, 72, 96 hours) Fowler et al. J Translational Medicine 2014;12:32 PMID
12 Plasma Vitamin C Concentration µmol/l IV : Intravenous Dosing O: Oral Dosing Oral Padayatty et al. Ann Intern Med. (2004) 140:533
13 Brain Assessing Organ Injury SOFA SCORE Respiratory Failure Liver Injury Bone Marrow Dysfunction Renal Failure Shock Extent of Pharmacologic Support
14 Sequential Organ Failure Assessment Score SOFA Lung (PaO2/FiO2 mm/hg) Brain (Coma) Cardiovascular (Shock) Liver (Bilirubin) Bone Marrow (Platelet) Renal Failure (Creatinine) < MAP<70 Mm/Hg <150 1 < Dopamine 5 µg/kg < < 200 mechanically ventilated Norepi 0.1 µg/kg < < 100 mechanically ventilated 4 <6 4 Norepi 0.1 µg/kg 4 >12 4 <20 4 >5 4 Organ Failure Scores SOFA Score = Sum of Organ Failure Scores
15 Phase I Safety Trial 31 patients screened 24 enrolled and randomized Placebo: (4M, 4F, age yrs) Lo-VitC: (5M, 3F, age yrs) Hi-VitC: (4M, 4F, age yrs) SOFA - Placebo: 13.1, SOFA - Lo-Vit C: 11.6 SOFA Hi-Vit C Fowler et al. J Translational Medicine 2014;12:32 PMID
16 Plasma Vitamin C Levels Fowler et al. J Translational Medicine 2014;12:32 PMID
17 Ascorbate Consumed In Sepsis By reduction of plasma free iron By the scavenging of aqueous free radicals By destruction of dehydroascorbic acid Destruction permits uncontrolled oxidant activity Galley et al. Free Rad Biol Med. 1996, 20 (1): , PMID:
18 SOFA Scores Fowler et al. J Translational Medicine 2014;12:32 PMID
19 Fowler et al. J Translational Medicine 2014;12:32 PMID
20 Fowler et al. J Translational Medicine 2014;12:32 PMID
21 Fowler et al. J Translational Medicine 2014;12:32 PMID
22 Intravenous Vitamin C Safe Mortality reduced Multiple organ failure significantly reduced Blood markers inflammation and vascular injury significantly attenuated Fowler et al. J Translational Medicine 2014;12:32 PMID
23 Plasma Vitamin C Augmentation Human Studies Lowered Incidence of ARDS and MOF in surgically critically ill Lowered capillary leak in patients with 50% full thickness burns Vit C + selenium + n-acetyl cysteine + Vit E lowered ARDS mortality by 50% (Published in abstract only) Nathens et al. Ann Surg. 2002, 236 (6): , PMID: Tanaka et al. Arch Surg. 2000, 135 (3): , PMID: Sawyer et al. Crit Care Med. 1989, 17: S153
24 Acute Respiratory Distress Syndrome: E. Coli Sepsis Baseline Day 2 Day 3 AM Day 3 PM Day 3 Intubation/Mechanical Ventilation Day 21
25 Neutrophil Activation NET Formation Bacteria Fungi Oxidants Proteases Cytokine Endotoxins NETOSIS
26 Activated Neutrophils Oxidants Proteases Proinflammatory lipids Cytokines Chemokines Cell Free DNA Alveolar Capillary
27 ARDS Bronchoalveolar Lavage Cytology
28 Vascular Endothelium Vitamin C Alveolar Epithelium Alveolar Space
29 Vitamin C Infusion
30 UM1 Program (Novel Therapies of Lung Diseases) Phase II multi-center trial proof of concept Randomized, double blinded, placebo-controlled Employ physiological and chemical measures of efficacy rather than mortality Data collected on well-characterized subjects Common drug with low toxicity Immuno-modulating therapy for ALI
31 Vitamin C Infusion for TReatment In Sepsis-Induced Acute Lung Injury CITRIS-ALI Assess Efficacy 96-hour Vitamin C Infusion (200 mg/kg/24 Hours) Septic Acute Lung Injury
32 CITRIS-ALI Multi-Center Trial VCU The Cleveland Clinic The Medical College of Wisconsin The University of Kentucky Emory University (First Trial Year) Proposed 170 patients with sepsis-induced ARDS Trial completed (November 2017)
33 Hypotheses Attenuate septic lung injury. (oxygenation index and V E 40) Attenuate sepsis-induced organ failure (SOFA Score) Attenuate injury biomarkers Inflammation Alveolar Epithelial Injury Fibrinolysis Vascular Injury Barrier Function
34 Exudative Proliferative Fibrotic Day Phases of ARDS
35 Sepsis Onset (Risk Period) Days Clinical Recognition of Organ Injury Immune Cell Activation Microvascular Thrombosis Bacteremia, Endotoxemia Cytokine Surge
36 X X X Exudative Proliferative Fibrotic Post Vitamin C Intervention Day Onset of ARDS Risk Period Timing of Intervention Prevention of ARDS
37 Biomarkers By Compartment
38 Systemic Inflammation C-Reactive Protein Procalcitonin
39 Alveolar Epithelial Injury C-Reactive Protein Procalcitonin Receptor for Advanced Glycation End Products (RAGE)
40 C-Reactive Protein Procalcitonin Receptor for Advanced Glycation End products RAGE Fibrinolysis Tissue Factor Pathway Inhibitor
41 C-Reactive Protein Procalcitonin Receptor for Advanced Glycation End products RAGE Tissue Factor Pathway Inhibitor Thrombomodulin Vascular Injury
42 C-Reactive Protein Procalcitonin Receptor for Advanced Glycation End products RAGE Tissue Factor Pathway Inhibitor Barrier Function Angiopoietin-2 Thrombomodulin
43 ONSET LUNG INJURY Active Treatment 200 mg/kg/day 50 mg/kg/every 6 hours 4 days
44 Assessment Schedule SOFA Score Plasma Ascorbate Biomarkers
45 Physiological Assessment Oxygenation Index. V E -40 OI = Mean Airway Pressure x F i O 2 P a O 2.. V E - 40 = V E X Weight (KG) PaCO 2 40
46 Responder Phenotype C-Reactive Protein and Procalcitonin RAGE Tissue Factor Pathway Inhibitor Serum-free Thrombomodulin Angiopoietin-2
47 Epidemiological Assessment (Secondary Outcomes) Day 28 Day 60 Ventilator Free Days ICU Free Days All Cause Mortality Hospital Free Days
48 Day 2 Day 1 Day 2 Day 4 Vit C Infusion Started Day 7 Day 13 Fowler et al. World J Crit Care Med. 2017;6:85-90, PMID:
49 Baseline Day 2 Day 7 Day 4 Vit C Infusion Started Baseline Day 4 Bharara et al. Case Rep Crit Care. 2016; PMID: Day 4 Vit C Infusion Started Day 10
50 Vitamin C Bacteremia Sepsis Burn INFECTION Fungemia Viremia Severe Sepsis Septic Shock Systemic Inflammatory Response Syndrome Trauma Pancreatitis Vitamin C
51
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