Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Osmol Gap Change
研究概览
简要总结
The goal of this observational study is to determine whether a clinically relevant dose of activated charcoal raises the serum osmolality and osmolal gap in a population of healthy volunteers. Secondarily to determine whether the same dose creates a false positive result using an enzymatic assay.
- Does a clinically relevant dose of commercially available activated charcoal raise the osmolal gap above the baseline of a healthy volunteer?
- Does the same dose of charcoal cause a false positive enzymatic assay for ethylene glycol?
Participants will be asked to consume a dose of activated charcoal and have serial blood draws for laboratory measurements.
详细描述
Healthy volunteers will be recruited and informed consent obtained. Exclusion criteria include acute illness or chronic condition requiring medication which would not be appropriate to discontinue due to risk for adsorption by activated charcoal.
Participants will fast prior to the study period and will have baseline laboratory measures (BMP, osmolality, ethanol, ethylene glycol). They will drink a dose of 1g/kg (max 100g) of activated charcoal suspension (Actidose Aqua) in water. Serial laboratory measurements will be made at 0.5, 1, 2,4, and 6 hours (including osmolality, osmolal gap, and ethylene glycol measured by enzymatic assay). These values will be compared to the pre-treatment values to determine if there is a change in the osmolal gap or ethylene glycol result from baseline.
This study is funded by the SUNY Upstate Department of Emergency Medicine and is approved by the IRB of the same institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
排除标准
- •Any medical comorbidities
- •Recent illness
- •Pregnancy
- •Prisoners
- •Non-English speaking
- •Weight > 100 kg
研究组 & 干预措施
Charcoal
Healthy volunteers to consume activated charcoal
干预措施: Activated Charcoal (Drug)
结局指标
主要结局
Osmol Gap Change
时间窗: 6 hours
Delta serum osmolality and osmolal gap at time points 0.5, 1, 2, 4, and 6 hours after Activated charcoal given
次要结局
- Ethylene Glycol(6 hours)