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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
Sponsor:
Information provided by (Responsible Party):
Brent W Morgan, MD, 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.

Condition or disease Intervention/treatment Phase
Phenytoin Toxicity Drug: Activated Charcoal Not Applicable

Detailed Description:
See above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Carl Skinner, MD Emory University

Publications of Results:
Responsible Party: Brent W Morgan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00823264     History of Changes
Other Study ID Numbers: IRB00008017
First Posted: January 15, 2009    Key Record Dates
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Brent W Morgan, MD, Emory University:
Anticonvulsants
Toxicology
multidose charcoal
phenytoin

Additional relevant MeSH terms:
Phenytoin
Charcoal
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Antidotes
Protective Agents
Physiological Effects of Drugs