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: September 4, 2014
Last verified: September 2014

January 14, 2009
September 4, 2014
August 2008
July 2010   (final data collection date for primary outcome measure)
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.
Serum Phenytoin 1/2 life. [ Time Frame: Every hours initially then once a day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823264 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 increase the elimination of phenytoin from the body.

See above

Interventional
Not Provided
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.
Other Name: Charcoal
  • 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
    Intervention: Drug: Activated Charcoal
  • No Intervention: Control
    Will not receive activated charcoal. Serum levels will be followed.
Skinner CG, Chang AS, Matthews AS, Reedy SJ, Morgan BW. Randomized controlled study on the use of multiple-dose activated charcoal in patients with supratherapeutic phenytoin levels. Clin Toxicol (Phila). 2012 Sep;50(8):764-9. doi: 10.3109/15563650.2012.716159. Epub 2012 Aug 17. Erratum in: Clin Toxicol (Phila). 2012 Dec;50(10):1176.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
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
September 2014

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