Sodium Nitrite for Out-of-Hospital Cardiac Arrest MICHAEL SAYRE, MD MEDICAL DIRECTOR, SEATTLE FIRE DEPARTMENT
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1 Sodium Nitrite for Out-of-Hospital Cardiac Arrest MICHAEL SAYRE, MD MEDICAL DIRECTOR, SEATTLE FIRE DEPARTMENT
2 Disclosures EMS Medicine Fellowship Director, University of Washington Physio-Control provides a significant grant to par@ally fund the fellow s salary and benefits. I receive travel reimbursement from the fund. We will discuss a poten@al indica@on, not approved by FDA, for an approved drug.
3 Half of OHCA pacents admieed to hospital following restoracon of pulses die of brain injury. The Hot Dog Study
4 Time Electrical Defibrillation
5 Time Hemodynamic CPR +? Epinephrine
6 Time Metabolic?
7 It s all about the mitochrondia.
8 Known protective effects of nitric oxide Vascular smooth muscle relaxation and vasodilation Inhibits leukocyte adhesion Suppression of Smooth muscle proliferation Inhibits platelet aggregation EC
9 QuesCon Will increasing nitric oxide (NO) levels in improve neurologic outcome following from cardiac arrest?
10 Possible approaches Inhaled nitric oxide gas Drugs that directly increase nitric oxide Nitroglycerin, Sodium nitroprusside Drugs that indirectly increase nitric oxide s effect Sildenafil
11
12 Sodium nitroprusside is not affordable
13 Can a different FDA approved drug serve as a source for nitric oxide?
14 Nitrite Nitrate NO NO 2 - NO 3 -
15 Oxy-Hb NO 3 - NO NO 2 - De-Oxy-Hb NO
16
17 The bad Nitrite as a food preserva@ve. FDA regulates it. Nitrosamines produced during acidic/high heat
18 Beet Juice: mg nitrite
19 What happens to nitrite levels during cardiac arrest? Nitrite Levels Inflammatory Arrest ROSC Time
20 Nitrite Levels Add nitrite to restore Blood levels Arrest ROSC Time
21 Mouse cardiac arrest model
22 SNOCAT Study Hypothesis Infusion of sodium nitrite during (before ROSC) will improve neurologic outcome and survival arer cardiac arrest.
23 SNOCAT: Sodium nitrite out of hospital cardiac arrest trial Phase 1 (dose finding and safety trial) n=100, expect 40 to survive to ED admission Open label, start dose of 25 mg. Achieve plasma level of 10 um?
24 Eligibility Out-of-hospital cardiac arrest (VF, non-vf) Unconscious/not following commands IV access/io Not in the three P s: Pregnant, Pediatric, Prisoners
25 Safety Data Being Collected Re-arrest Use of vasopressors: norepinephrine or epinephrine infusions Blood Draws for NO 2 levels at ED or in field For Harborview Medical Center only addi@onal draws at 20, 40, 60, 80, 100, 120 points
26 Endpoints Plasma level of nitrite at hospital, ED arrival Safety: re-arrest, use of pressors N=100 (expect 40 to be admi_ed to ED)
27 SNOCAT: Sodium nitrite out of hospital cardiac arrest trial Phase 2 (safety and efficacy) n=1000, expect 400 to survive to ED Randomized/blinded Primary endpoint: Survival to ED (safety endpoint) Secondary endpoint: Survival to discharge
28 SNOCAT InvesCgators Francis Kim Peter Kudenchuk Graham Nichol Michele Olsuea Michael Sayre Sue Scruggs Chuck Maynard Susanne May
29 Safety Low risk for hypotension No risk for methemoglobin Restores nitrite level to baseline Given post-arrest at doses up to 9 mg, no significant effects Effect during resuscita@on unknown?
30 The good Increases NO levels in blood (blood pressure lowering effects) May protect blood vessels Found in supplements (increase endurance)
31
32 Ischemia/reperfusion X X X Superoxide Nitric oxide Hydrogen sulfide Carbon monoxide
33 NO CO H 2 S Toxic Gas? Exhaust, air pollution Air pollution Sewers, swamps Produced by cells Nitric oxide synthase (NOS) nitrite Made from hemoglobin Synthesized from L-cysteine Vascular effects Vasodilates Vasodilates Vasodilates Anti-inflammatory effects Yes Yes Yes Mitochondrial Decrease Decrease Decrease
34 Membrane permeability Coagulation activation x Ischemia Reperfusion Injury Inflammatory Response x Ca 2+, glutamate x NO Brain cell injury/death
35 NO-ischemia role of nitric oxide in ischemia reperfusion (liver,heart, brain) overexpression studies Drug (NO-donor) (different structures)
36 NO produccon is reduced during ischemia Nitric oxide by NOS requires oxygen (not suitable for ischemia) Nitric oxide requires cofactors (limited during ischemia)
37 Dezfulian, C. et al. Cardiovasc Res : ; doi: /j.cardiores The NO-nitrite-nitrate pool
38
39
40 IV nitrite in acute ST elevacon MI 229 pts randomized (70 um, 5 mg over 5 minutes) or placebo before coronary interven@on Mean nitrite level at randomiza@on (.70 um) Nitrite (1.42 um) vs. placebo (.18 um) 5 min arer comple@on of infusion Siddiqu N, European Heart Journal 2014
41 Siddiqi N et al. Eur Heart J 2014;35: The Author Published by Oxford University Press on behalf of the European Society of Cardiology.
42 Clinical-nitrites Peripheral arterial disease (oral doses mg)-2014 CHF (17.5 mg)-2015 Organ for transplant Cardiac arrest (post) (1-14 mg)
43
44
45
46 Coagulation activation Membrane permeability Ischemia Reperfusion Injury Inflammatory Response Ca 2+ glutamate Brain cell injury/death
47
48 Ischemia/reperfusion Superoxide
49 Ischemia/reperfusion X X X Superoxide
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