Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Proportion of cases where successful randomization occurred
研究概览
简要总结
The purpose of this pilot interventional study is to collect preliminary data on administering magnesium sulfate as a neuroprotective medication in patients who achieved Return of Spontaneous Circulation (ROSC) following Cardiac Arrest (CA). The primary aims are to assess the feasibility and safety of administering magnesium and measure serum markers of neuronal injury at prespecified time points in the post-cardiac arrest period. Because this is a pilot study with a limited sample size, the primary objective is to evaluate the precision and stability of the collected measures to inform the design and formal analysis in a larger trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved <2 hours prior to recruitment
排除标准
- •Age < 18 years or > 85 years
- •Traumatic cardiac arrests
- •Unsustained ROSC (<20 minutes)
- •Patient who is responsive/able to follow motor commands within 1 hour of achieving ROSC
- •Plan for withdrawal of life support within 72 hours of ROSC
- •Known pregnant women at the time of the cardiac arrest
- •Known prisoners at the time of the cardiac arrest
- •Subjects who have a medical o social condition that would make them inappropriate for the study based on the PI's or clinical team judgement.
研究组 & 干预措施
Saline solution
Treatment of equivalent volume of normal saline.
干预措施: Saline (Drug)
Magnesium Sulfate
Treatment of initial magnesium sulfate bolus followed by a continuous drip.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Proportion of cases where successful randomization occurred
时间窗: Through study completion, an average of 90 days
Proportion of cases where Magnesium (Mg) or saline bolus was delivered with a goal of <2 h after return of spontaneous circulation (ROSC)
时间窗: Through study completion, an average of 90 days
Proportion of cases with adherence to treatment protocol
时间窗: Through study completion, an average of 90 days
Assessment of adherence will involve reviewing chart data to evaluate the timing of medication order placement and timing of administration by the nurse.
Proportion of cases for which serum is successfully drawn and analyzed
时间窗: Through study completion, an average of 90 days
Proportion of cases where patient's Cerebral Performance Category Score (CPC) status is assessed
时间窗: At hospital discharge, on average 3 weeks
The CPC assessment score will be derived from the patient's electronic medical record (EMR).
Proportion of cases where patient's CPC status is assessed
时间窗: Day 90
The CPC assessment score will be derived from the patient's EMR.
Proportion of cases where patient's CPC status is assessed
时间窗: Day 30
The CPC assessment score will be derived from the patient's EMR.
次要结局
- All-cause mortality(Day 90)
- Proportion of cases for which magnesium levels are found to be >6 mg/dl(Through study completion, an average of 90 days)
- Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl(Through study completion, an average of 90 days)
- Number of participants with adverse reactions related to magnesium therapy(Through study completion, an average of 90 days)
- Proportion of cases for which magnesium levels are found to be >10 mg/dl(Through study completion, an average of 90 days)
- Proportion of patients with unfavorable neurological outcomes(Day 90)
- Proportion of patients with unfavorable neurological outcomes(At hospital discharge, on average 3 weeks)
- Proportion of patients with unfavorable neurological outcomes(Day 30)