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临床试验/NCT00823264
NCT00823264已完成不适用

Prospective Randomized Study of Multidose Activated Charcoal in Supratherapeutic Phenytoin Serum Levels

Emory University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels

研究概览

简要总结

Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from the blood. This is theorized to occur as charcoal absorbs phenytoin from across the intestines and then is secreted in the stool. Patients will be selected to receive either charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to follow their level. The different groups will then be compared to see if multidose charcoal does indeed increase the elimination of phenytoin from the body.

详细描述

See above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Phenytoin level > 30 mg/L

排除标准

  • Age < 18
  • Known allergy to Activated Charcoal
  • Inability to take PO drugs
  • Non English speaking
  • Inability to give consent
  • Any prisoners

研究组 & 干预措施

Multiple Doses of Activated Charcoal

Experimental

Patients will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels drop below 25 ug/cc

干预措施: Activated Charcoal (Drug)

结局指标

主要结局

Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels

时间窗: Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours

We enrolled patients with elevated phenytoin levels into the study with greater than 30 ug/cc. The treatment arm received multiple doses of activated charcoal and the control arm received no activated charcoal. We obtained serum phenytoin levels every 6 hours for 24 hours then once every 24 hours. The time to reach a subtoxic level was determined in each arm by looking at serum phenytoin levels and documenting when it was below 25 ug/cc.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent W Morgan, MD

Associate Professor

Emory University

研究点 (1)

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