Phenytoin and Multidose Activated Charcoal
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|ClinicalTrials.gov Identifier: NCT00823264|
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Phenytoin Toxicity||Drug: Activated Charcoal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study of Multidose Activated Charcoal in Supratherapeutic Phenytoin Serum Levels|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||January 2012|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823264
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Carl Skinner, MD||Emory University|