Phenytoin and Multidose Activated Charcoal
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Study of Multidose Activated Charcoal in Supratherapeutic Phenytoin Serum Levels|
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: 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
Drug: Activated Charcoal
50 grams by mouth every 4 hours until serum phenytoin level is less than 25.
Other Name: Charcoal
No Intervention: Control
Will not receive activated charcoal. Serum levels will be followed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823264
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Carl Skinner, MD||Emory University|