Neuroprotection following cardiac arrest: A Randomized Control Trial of Magnesium
心脏骤停后的神经保护:镁的随机对照试验
基本信息
- 批准号:10742460
- 负责人:
- 金额:$ 25.43万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-01 至 2026-06-30
- 项目状态:未结题
- 来源:
- 关键词:Adverse eventAmerican Heart AssociationAnimalsAnoxiaAnoxic EncephalopathyApoptosisAttenuatedBiological AssayBiological MarkersBloodBlood PressureBlood flowBrainBrain InjuriesCardiopulmonary ResuscitationCaringCell DeathCessation of lifeCirculationCollectionCritical CareDataData CollectionDedicationsEligibility DeterminationEnzymesEventGoalsGrantHeart ArrestHospitalsHourHumanIncidenceInflammationInflammatoryInformed ConsentInfrastructureInjuryInstitutional Review BoardsInternationalInterventionIschemiaLinkMK801MagnesiumMeta-AnalysisMethodsMg supplementationMinocyclineMitochondriaMorbidity - disease rateMulti-Institutional Clinical TrialN-Methyl-D-Aspartate ReceptorsNMDA receptor antagonistNervous System PhysiologyNeurological outcomeNeurological statusNeuroprotective AgentsNormal salineOdds RatioOutcomeOxidative StressPathway interactionsPatientsPilot ProjectsPlacebosProcessProcess AssessmentProcess MeasureRandomizedRandomized, Controlled TrialsReperfusion InjuryReperfusion TherapyResearchResearch DesignResearch PersonnelResuscitationRetrospective StudiesSamplingSeriesSerumSerum MarkersSiteStandardizationStrokeSurvival RateSurvivorsTemperatureTestingTimeTraumatic Brain InjuryVentilatorWorkdesignexcitotoxicityfeasibility testingimprovedmortalityneuroprotectionnoveloxidative damagepharmacologicpilot testpreventrecruitsafety and feasibilitysample collectionsecondary endpointsevere injurystandard of caresurvival outcometimeline
项目摘要
Project Summary/Abstract
Cardiac arrest has an estimated annual incidence of 250-350,000 out-of-hospital and 250-750,000 in-hospital
events in the U.S., with survival rates as low as 5% and 20% respectively. These outcomes reflect a two-step
injury process: a) ischemia during cessation of blood flow and b) secondary reperfusion and inflammatory injury
following return of spontaneous circulation (ROSC). With only 3-7% of CA survivors recovering to their pre-CA
neurological status, developing interventions to attenuate reperfusion injury are critical to improve patients’
survival and neurological outcomes. A series of animal and human studies have shown that the use of
pharmacological interventions targeted against excitoxicity, oxidative injury and inflammatory pathways may
reduce ischemia/reperfusion injury and improve post-CA survival and neurological outcomes. A small-scale
randomized control trial (RCT) has provided preliminary evidence to support the hypothesis that magnesium
(Mg) in the post-CA period as a neuroprotective agent may improve neurological outcomes among survivors.
However, additional data is needed to support its use as standard of care in the post-CA period. We therefore
propose to collect necessary and sufficient data to design a multisite RCT of Mg neuroprotection following CA.
We hypothesize that administering Mg in the post-CA period is feasible and safe, and that it may attenuate
excitotoxity, thereby ameliorating the downstream cascade of reperfusion injuries associated with morbidity and
mortality. The current application proposes three aims: For Aim 1, a single site pilot RCT will assess the feasibility
and safety of administrating Mg and collecting serum samples post-CA. The effects of Mg on serum markers of
brain injury, inflammation, and oxidative stress, as well as, rates of ROSC, survival and independent neurological
function will also be assessed. For Aim 2, researchers will establish single-IRB (S-IRB) approval for a multi-site
pilot RCT of Mg post-CA using Exception From Informed Consent (EFIC). Eligible sites will then be invited to
participate in a pilot study. For Aim 3, sites identified in Aim 2 will demonstrate capacity for recruitment and data
collection by administering the Mg therapy in up to 4 and placebo in up to 4 post-CA patients. The data obtained
through the execution of Aims 1-3 will be used to inform the design and implementation of a large-scale trial to
assess the impact of Mg (with standard post-CA care) versus placebo (with standard post-CA care) on survival
and independent neurological function after CA.
项目总结/文摘
项目成果
期刊论文数量(0)
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Sam Parnia其他文献
Sam Parnia的其他文献
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{{ truncateString('Sam Parnia', 18)}}的其他基金
Goal directed cardiopulmonary resuscitation in cardiac arrest using a novel physiological target: A pilot mechanistic randomized control trial
使用新型生理目标进行心脏骤停的目标导向心肺复苏:一项试点机械随机对照试验
- 批准号:
10698018 - 财政年份:2020
- 资助金额:
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10896626 - 财政年份:2020
- 资助金额:
$ 25.43万 - 项目类别:
Goal directed cardiopulmonary resuscitation in cardiac arrest using a novel physiological target: A pilot mechanistic randomized control trial
使用新型生理目标进行心脏骤停的目标导向心肺复苏:一项试点机械随机对照试验
- 批准号:
10471231 - 财政年份:2020
- 资助金额:
$ 25.43万 - 项目类别:
Paradoxical lucidity in severe end stage dementia: a mixed methods prospective study
严重末期痴呆的矛盾清醒:一项混合方法前瞻性研究
- 批准号:
10095286 - 财政年份:2020
- 资助金额:
$ 25.43万 - 项目类别:
Goal directed cardiopulmonary resuscitation in cardiac arrest using a novel physiological target: A pilot mechanistic randomized control trial
使用新型生理目标进行心脏骤停的目标导向心肺复苏:一项试点机械随机对照试验
- 批准号:
10228545 - 财政年份:2020
- 资助金额:
$ 25.43万 - 项目类别:
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