Prospective Randomized Study of Multidose Activated Charcoal in Supratherapeutic Phenytoin Serum Levels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels
Study Overview
Brief Summary
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
See above
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Phenytoin level > 30 mg/L
Exclusion Criteria
- •Age < 18
- •Known allergy to Activated Charcoal
- •Inability to take PO drugs
- •Non English speaking
- •Inability to give consent
- •Any prisoners
Arms & Interventions
Multiple Doses of Activated Charcoal
Patients will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels drop below 25 ug/cc
Intervention: Activated Charcoal (Drug)
Outcomes
Primary Outcomes
Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Brent W Morgan, MD
Associate Professor
Emory University