Phenytoin and Multidose Activated Charcoal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brent W Morgan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00823264
First received: January 14, 2009
Last updated: August 13, 2013
Last verified: August 2013

January 14, 2009
August 13, 2013
August 2008
July 2010   (final data collection date for primary outcome measure)
Serum Phenytoin 1/2 life. [ Time Frame: Every hours initially then once a day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00823264 on ClinicalTrials.gov Archive Site
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Phenytoin and Multidose Activated Charcoal
Prospective Randomized Study of Multidose Activated Charcoal in Supratherapeutic Phenytoin Serum Levels

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 shorten the half-life of phenytoin in the blood.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Phenytoin Toxicity
Drug: Activated Charcoal
50 grams by mouth every 4 hours until serum phenytoin level is less than 25.
  • Experimental: 1
    Patients will receive multiple doses of activated charcoal
    Intervention: Drug: Activated Charcoal
  • No Intervention: 2
    Will not receive activated charcoal. Serum levels will be followed.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
January 2012
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823264
IRB00008017
No
Brent W Morgan, MD, Emory University
Emory University
Not Provided
Principal Investigator: Carl Skinner, MD Emory University
Emory University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP