Hydrocortisone, Ascorbic Acid and Thiamine for the Treatment of Severe Sepsis and Septic Shock
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1 z Hydrocortisone, Ascorbic Acid and Thiamine for the Treatment of Severe Sepsis and Septic Shock z
2 Disclosures Advisory board Stocks Grants Patents Speaker bureau
3 Sepsis in a Global Problem > 50 Million cases of sepsis / year Sepsis mortality ~ 60% resource poor countries Commonest cause of death in children ~ 5 million / year > 20 Million deaths / year
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6 William Osler Except for a few occasions patients appear to die from the body s response to infection rather than from it
7 Pro-inflammatory cytokines Anti-inflammatory cytokines Chemokines Adhesion molecules Transcription factors Enzymes Clotting factors Stress proteins Etc, etc 3714 unique genes Calvano SE et al. Nature 2005;437:3985
8 Unifying Pathophysiology
9 Pro-Inflammatory cytokines and ROS
10 Lancet 2002;360:219
11 Why Patients with Sepsis Die? Cellular Bioenergetic (Metabolic) Failure Tissue Hypoxia
12 Failed Novel Pharmacologic Agents for Sepsis > 100 Phase II and III clinical trials E.Coli J5 antisera Anti-lipid A E5 mab Anti-lipid A HA1A mab Anti-TNF mab Chimeric TNF mab Humanized TNF mab stnfr1:fc stnfr2:fc Anti-CD 14 mab Tissue factor pathway inhibitor Platelet activating factor receptor antagonist IL-1 receptor antagonist Bactericidal permeability increasing protein Selenium Immunoglobulins rhdl and phospholipid complexes Activated Protein C N-acetyl cysteine Antithrombin III Statins NOS inhibitors Phospholipase A-II inhibitor Granulocyte stimulating factor Bradykinin antagonist Elastase inhibitor TAK-242, Toll-4 inhibitor Eritoran, MD2-TLR4 antagonist Anti-β2 integrin Lactoferrin RT-123, r-human soluble Thrombomodulin Ibuprofen
13 the best hope for therapeutic advances [in sepsis] will depend on broad-base targeting, in which multiple components are targeted at the same time. Aird, W.C., Blood, 2003
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16 Steps to the Cure Early Diagnosis Early administration of the correct antibiotics, in the correct dose Source Control Conservative, individualized, physiologic approach to fluid resuscitation Early use of Norepinephrine The Metabolic Resuscitation Protocol (HAT) Hydrocortisone, Ascorbic Acid & Thiamine Multidisciplinary, team approach to patient care State-of-the-art evidence based supportive care
17 The changing paradigm of Sepsis: Early diagnosis, Early antibiotics, Early pressors and Early adjuvant treatment Marik & Fargas, Crit Care Med 2018;46:1690
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19 Pivotal First Case (Jan. 2016) 53 female presents with AMS (per family) In ER: 47/20 mmhg, HR 122, Temp 38.5, jaundice, tender RUQ WBC with 9% bandemia, Cr 3.2 mg/dl Lactate 4.4 mmol/l PCT 59 ng/ml T-Bili 7.8 mg/dl, AST 140 U/l, ALT 170 U/l Ab U/S + CT: acute cholecystitis Zosyn and vancomycin Rapid diagnosis and admission to ICU
20 Pivotal First Case In ICU - Day 1 Escalating doses of pressors; fluid non-responsive Intubation IR: percutaneous cholecystotomy tube ARF CRRT commenced ECHO: EF 15% previously 55%
21 The Metabolic Resuscitation Protocol Hydrocortisone Anti-inflammatory Increases pressor sensitivity Preserves/restores endothelial integrity Cheap Safe Vitamin C Anti-inflammatory Increases pressor sensitivity Preserves/restores endothelial integrity Cheap Safe
22 Pivotal First Case In ICU - Day 1 Escalating doses of pressors; fluid non-responsive Intubation IR: percutaneous cholecystotomy tube ARF CRRT commenced ECHO: EF 15% previously 55% Vitamin C + Hydrocortisone
23 Pressor dose vs time Time (hrs) vs Phenylephrine Time (hrs) vs Norepinephrine Time (hrs) vs Vasopressin Phenylephrine (ug/min) Norepinephrine (ug/min) Vasopressin u/min Vitamin C + Hydrocortisone Time (Hrs)
24 Pivotal First Case In ICU - Day 2 Pressors weaned off Extubated (awake and alert) Increase U/O In ICU - Day 3 CRRT stopped BC: E.coli + Clostridia perfringens EF 40% Day 4 transfer to medical floor Day 8 sent home; to return for cholecystectomy
25 Pivotal First Case (n=1) With Consent from patient
26 Philosophy of the Hydrocortisone, Ascorbic Acid and Thiamine (HAT) Protocol Targets the hosts response to infection Anti-inflammatory + antioxidant W N E Multiple agents with overlapping and synergistic actions S SAFE No side effects CHEAP and readily available
27 The Study
28 Chest; 2017;151 (June);
29 Methods Treatment Group January 2016 to July 2016 (7 months) All consecutive pts adm. to MICU with primary diagnosis of sepsis Procalcitonin (PCT) > 2ng/ml Rx: Vitamin C protocol within 24 hours ICU admission Control Group June 2015 to December 2015 (7 months) All consecutive pts adm. to MICU with primary diagnosis of sepsis Same inclusion criteria (as above) Standard evidence based management strategy during both time periods Exclusion Criteria Age < 18 yrs Pregnancy Limitations of care
30 Characteristic Patient Characteristics Treatment n=47 Control * n=47 Age 58.3 ± ± 16.5 Male 27 (57%) 23 (49%) Mechanical ventilation 22 (47%) 26 (55%) Vasopressors 22 (46%) 22 (46%) PCT (<0.05 ng/ml) 25.8 ( ) 15.2 ( ) Day 1 SOFA 8.3 ± ± 3.7 APACHE II 22.1 ± ± 5.7 APACHE IV 79.5 ± ±27.4 Predicted Mortality* 39.7 ± ± 24.2 Vitamin C (40-60 umol/l) n=22 * No significant differences between groups 14.1 ±
31 M o r ta lity (% ) Outcome * P re d ic te d M o rta lity A c tu a l M o rta lity * p< C o n tr o l T r e a tm e n t
32 Propensity Adjusted Outcome
33 Time to pressor discontinuation Treatment Group Pressor Dosage Over Time Norepineprine eq ug/min Hours Mean time to discontinuation of all pressors 18.3 ± 9.8
34 Sofa Score Over Time
35 S-Cr over time Treatment Group Excluding CRF S-Creatinine mg/dl Discharge 5 6 Day
36 s-lactate over time Lactate mmol/l Days Lactate - Treatment Lactate - Control
37 Procalcitonin Over Time 1000 Procalcitonin ng/ml Day Treatment Control
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39 The Impact of Social Media Very Cool Snake oil Fairy dust Utter crap
40 Jabaley CS, et al. J Crit Care 2018; 357
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43 Simon Finfer, Chair
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46 The Experience of other! > s Josh from NH
47 Gerald from SC. Post-chemo septicemia. Semi comatose. Given three days to live. Dr. Says it s in Gods hands...nothing can be done.
48 24 hours later; Rx with HAT
49 Characteristic Treatment n=53 Control n=46 Age Pressors 62% 48% Mechanical Ventilation 81% 78% APACHE II SOFA Kim et al. J Intensive Care Med 2018; 47:211
50 Propensity adjusted OR 0.15 ( ), p=0.005
51 Updated Meta-analysis NNT = 4.3 NNH =
52 ~ -$ QALY
53 Vitamin C Ascorbic acid
54 Oxalate
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56 Ascorbic Acid 70 kg goat synthesizes 2-4 g/day
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59 Ascorbic Acid An essential vitamin for humans who lack L-gulono-lactone oxidase, the final enzyme in the biosynthetic pathway Vitamin C acts free radical scavenger and co-enzyme multiple reactions Absorbed by gut by sodium-dependent transporters (SVCT1) Vitamin C circulates in human plasma at µm Transported into cells by SVCT2 reaches mm concentrations
60 Sodium-Vitamin C Transporters- SVCT
61 Ann Intern Med 2004;140:533
62 Ascorbic Acid All mammals except primates and Guinea Pigs increase Vitamin C synthesis during stress Vitamin C levels are typically very low in critically ill patients Low levels likely due to enhanced metabolic turnover (oxidant stress) Decreased GI absorption (dec. expression of SVCT1) Urinary loss 100% septic patients levels < 23 umol/l (Vitamin C deficient) ~40% septic patients levels < 11.3 umol/l - Scurvy Low levels despite PO supplementation 1500 mg/day
63 Key Roles of Vitamin C is Sepsis Key Role Free radical scavenger Anti-inflammatory Microcirculation Immune function Anti-thrombotic Synthesis of catecholamines Wound Healing Mechanism Scavenges extracellular, intracellular and mitochondrial ROS; limits oxidation of mitochondrial proteins, enzymes, lipoproteins, cell membrane, etc Inhibits activation of NFκB, decreases HMGB1, inhibits histamine, prevents NETosis, inactivates HIF-1α Increases enos, decreases inos, preserves tight junctions Supports lymphocyte proliferation, increases neutrophil bacteriocidal action, improves chemotaxis, stimulates interferon production, decreases T regulatory cells (Tregs) Decreases platelet activation and tissue factor expression, increases thrombomodulin Acts cofactor in synthesis of epinephrine, dopamine and vasopressin. Increases adrenergic sensitivity Hydroxylation of procollagen, increased expression of collagen mrna
64 Thiamine, Oxalate and Vitamin C
65 32% Donnino MW et al. Crit Care Med 2016; 44; 360
66 Ann Thorac Med 2017;14:737
67 Thiamine and Oxidative Phosphorylation
68 Oxidation to CO2 Oxidation to Co2 Pyridoxal phosphate (reqd coenzyme) Thiamine-pyrophosphate (reqd coenzyme)
69 The Synergy Between Glucocorticoids and Vitamin C
70 I/R + placebo I/R + Vitamin C (50 mg/kg) I/R + hydrocortisone I/R + Combination Iran J Pathol 2015;10:272
71 Chest 2017;152:
72 Results: Hydrocort.+ Vitamin C and LPS (post LPS)
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74 Hydrocortisone, Ascorbic acid & Thiamine (HAT) for the treatment of sepsis
75 Chain of evidence Validated mechanistic basis Supported by basic science Supported by clinical studies
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