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Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest.

ABSTRACT: It is hypothesized that intravenous (IV) sodium nitrite given during resuscitation of out-of-hospital cardiac arrest (OHCA) will improve survival. We performed a phase 1 open-label study of IV sodium nitrite given during resuscitation of 120 patents with OHCA from ventricular fibrillation or nonventricular fibrillation initial rhythms by Seattle Fire Department paramedics. A total of 59 patients received 25 mg (low) and 61 patients received 60 mg (high) of sodium nitrite during resuscitation from OHCA. Treatment effects were compared between high- and low-dose nitrite groups, and all patients in a concurrent local Emergency Medical Services registry of OHCA. Whole blood nitrite levels were measured in 97 patients. The rate of return of spontaneous circulation (48% vs 49%), rearrest in the field (15% vs 25%), use of norepinephrine (12% vs 12%), first systolic blood pressure (124 ± 32 vs 125 ± 38 mm Hg), survival to discharge (23.7% vs 16.4%), and neurologically favorable survival (18.6% vs 11.5%) were not significantly different in the low and high nitrite groups. There were no significant differences in these outcomes among patients who received IV nitrite compared with concurrent registry controls. We estimate that 60 mg achieves whole blood nitrite levels of 22 to 38 ?M 10 minutes after administration, whereas 25 mg achieves a level of 9 to 16 ?M 10 minutes after delivery. In conclusion, administration of IV nitrite is feasible and appears to be safe in patients with OHCA, permitting subsequent evaluation of the effectiveness of IV nitrite for the treatment of OHCA.

SUBMITTER: Kim F

PROVIDER: S-EPMC6515919 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest.

Kim Francis F Dezfulian Cameron C Empey Philip E PE Morrell Matthew M Olsufka Michele M Scruggs Sue S Kudenchuk Peter P May Susanne S Maynard Charles C Sayre Michael R MR Nichol Graham G

The American journal of cardiology 20180620 4

It is hypothesized that intravenous (IV) sodium nitrite given during resuscitation of out-of-hospital cardiac arrest (OHCA) will improve survival. We performed a phase 1 open-label study of IV sodium nitrite given during resuscitation of 120 patents with OHCA from ventricular fibrillation or nonventricular fibrillation initial rhythms by Seattle Fire Department paramedics. A total of 59 patients received 25 mg (low) and 61 patients received 60 mg (high) of sodium nitrite during resuscitation fro ...[more]

PMID: 30205886

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Project description:ImportanceTherapeutic delivery of sodium nitrite during resuscitation improved survival in animal models of cardiac arrest, but efficacy has not been evaluated in clinical trials in humans.ObjectiveTo determine whether parenteral administration of sodium nitrite given by paramedics during resuscitation for out-of-hospital cardiac arrest improved survival to hospital admission.Design, setting, and participantsDouble-blind, placebo-controlled, phase 2 randomized clinical trial including 1502 adults in King County, Washington, with out-of-hospital cardiac arrest from ventricular fibrillation or nonventricular fibrillation. Patients underwent resuscitation by paramedics and were enrolled between February 8, 2018, and August 19, 2019; follow-up and data abstraction were completed by December 31, 2019.InterventionsEligible patients with out-of-hospital cardiac arrest were randomized (1:1:1) to receive 45 mg of sodium nitrite (n = 500), 60 mg of sodium nitrite (n = 498), or placebo (n = 499), which was given via bolus injection by the paramedics as soon as possible during active resuscitation.Main outcomes and measuresThe primary outcome was survival to hospital admission and was evaluated with 1-sided hypothesis testing. The secondary outcomes included out-of-hospital variables (rate of return of spontaneous circulation, rate of rearrest, and use of norepinephrine to support blood pressure) and in-hospital variables (survival to hospital discharge; neurological outcomes at hospital discharge; cumulative survival to 24 hours, 48 hours, and 72 hours; and number of days in the intensive care unit).ResultsAmong 1502 patients with out-of-hospital cardiac arrest who were randomized (mean age, 64 years [SD, 17 years]; 34% were women), 99% completed the trial. Overall, 205 patients (41%) in the 45 mg of sodium nitrite group and 212 patients (43%) in the 60 mg of sodium nitrite group compared with 218 patients (44%) in the placebo group survived to hospital admission; the mean difference for the 45-mg dose vs placebo was -2.9% (1-sided 95% CI, -8.0% to ∞; P = .82) and the mean difference for the 60-mg dose vs placebo was -1.3% (1-sided 95% CI, -6.5% to ∞; P = .66). None of the 7 prespecified secondary outcomes were significantly different, including survival to hospital discharge for 66 patients (13.2%) in the 45 mg of sodium nitrite group and 72 patients (14.5%) in the 60 mg of sodium nitrite group compared with 74 patients (14.9%) in the placebo group; the mean difference for the 45-mg dose vs placebo was -1.7% (2-sided 95% CI, -6.0% to 2.6%; P = .44) and the mean difference for the 60-mg dose vs placebo was -0.4% (2-sided 95% CI, -4.9% to 4.0%; P = .85).Conclusions and relevanceAmong patients with out-of-hospital cardiac arrest, administration of sodium nitrite, compared with placebo, did not significantly improve survival to hospital admission. These findings do not support the use of sodium nitrite during resuscitation from out-of-hospital cardiac arrest.Trial registrationClinicalTrials.gov Identifier: NCT03452917.

Project description:Importance:Out-of-hospital cardiac arrest is a common scenario facing prehospital emergency medical services (EMS) professionals and nearly always involves either manual or mechanical cardiopulmonary resuscitation (CPR). Mechanical CPR devices are expensive and prior clinical trials have not provided evidence of benefit for patients when compared with manual CPR. Objectives:To investigate the use of mechanical CPR in the prehospital setting and determine whether patient demographic characteristics or geographical location is associated with its use. Design, Setting, and Participants:A retrospective cross-sectional study was performed using the 2010 through 2016 National Emergency Medical Services Information System data. Participants included all patients identified by EMS professionals as having out-of-hospital cardiac arrest. Main Outcomes and Measures:Use of CPR, categorized as manual or mechanical. Results:From 2010 to 2016, 892?022 patients (38.6% female, 60.4% male, missing for 1%; mean [SD] age, 61.1 [20.5] years) with out-of-hospital cardiac arrest were identified by EMS professionals. Overall, manual CPR was used for 618?171 patients (69.3%) and mechanical CPR was used for 45?493 patients (5.1%). The risk-standardized rate of mechanical CPR use, accounting for patient demographic and geographical characteristics, rose from 1.9% in 2010 to 8.0% in 2016 (P?<?.001). In multivariable analyses, use of mechanical CPR devices was increasingly likely over time among patients identified with out-of-hospital cardiac arrest treated by EMS professionals, increasing from an adjusted odds ratio of 1.58 (95% CI, 1.42-1.77; P?<?.001) when comparing 2011 with 2010, to an adjusted odds ratio of 11.32 (95% CI, 10.22-12.54; P?<?.001) when comparing 2016 with 2010. In addition, several other patient demographic and geographical characteristics were associated with a higher likelihood of receiving mechanical CPR, including being 65 years or older, being male, being Hispanic, as well as receiving treatment in the Northeast Census Region, in a suburban location, or in a zip code with a median annual income greater than $20?000. Conclusions and Relevance:Mechanical CPR device use increased more than 4-fold among patients with out-of-hospital cardiac arrest treated by EMS professionals. Given the high costs of mechanical CPR devices, better evidence is needed to determine whether these devices improve clinically meaningful outcomes for patients treated for out-of-hospital cardiac arrest by prehospital EMS professionals to justify the significant increase in their use.

Dataset Information

Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest.

Publications

Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest.

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