Phenytoin and Multidose Activated Charcoal

Not Applicable

Completed

• Conditions: Phenytoin Toxicity
• Interventions: Drug: Activated Charcoal

• Registration Number: NCT00823264
• Lead Sponsor: Emory University

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2010-07
• Study Completion: 2012-01
• Results First Submitted: 2013-08-14
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Results First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Doses of Activated Charcoal	Activated Charcoal	Patients will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels drop below 25 ug/cc

Primary Outcome Measures

Name	Time	Method
Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels	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.

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States