MAST - Magnesium for Sickle Cell Acute Crisis in Children
研究概览
详细说明
Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.
In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5G 1X8
- The Hospital for Sick Children
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Known sickle cell disease
- Previous painful crisis resulting in an Emergency Department(ED) visit
- Current visit with a chief complaint of pain
- Age 4 years - 18 years
- Staff ED decides to admit to the hospital
- Staff ED decides to start an intravenous line
Exclusion Criteria:
- Fever (>38.5C) during the 24 hours prior to visit at triage
- Patients transfused within 90 days of study entry
- Patients with known renal disease
- Patients with known heart block or myocardial damage
- Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
- Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours
- Patients or parents unable to communicate in English
- Known pregnancy
- Known allergy to Magnesium
- Admission to the ICU
- Enrolment to the study in the last 30 days
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1个
|
Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
|
|
安慰剂比较：2个
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Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Length of stay in the hospital
大体时间：Time frame determined by outcome
|
Time frame determined by outcome
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Reduction mean daily pain score during an admission for sickle cell pain crisis
大体时间：Length of hospital stay
|
Length of hospital stay
|
|
Adverse events during admission
大体时间：Length of hospital stay
|
Length of hospital stay
|
|
Cumulative Narcotic drug required to manage the crises during admission
大体时间：Length of hospital stay
|
Length of hospital stay
|
合作者和调查者
调查人员
- 首席研究员：Jeremy Friedman, MD、The Hospital for Sick Children, Toronto Canada
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.