Phenytoin and Multidose Activated Charcoal

Study Overview
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Brief Summary
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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.

Detailed Description
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See above

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

Conditions
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Phenytoin Toxicity

Intervention / Treatment
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* Drug: Activated Charcoal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phenytoin level > 30 mg/L Exclusion Criteria: Age < 18 Known allergy to Activated Charcoal Pregnant Inability to take PO drugs Non English speaking Inability to give consent Any prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Doses of Activated Charcoal<br>Patients will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels drop below 25 ug/cc | Drug: Activated Charcoal<br>* 50 grams by mouth every 4 hours until serum phenytoin level is less than 25.<br>* Other names: Charcoal;|
| No Intervention: Control<br>Will not receive activated charcoal. Serum levels will be followed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels | 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. | Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticonvulsants, Toxicology, multidose charcoal, phenytoin