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
  Purpose

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 Intervention
Phenytoin Toxicity
Drug: Activated Charcoal

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Brent W Morgan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00823264     History of Changes
Other Study ID Numbers: IRB00008017
Study First Received: January 14, 2009
Results First Received: August 14, 2013
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Anticonvulsants
Toxicology
multidose charcoal
phenytoin

Additional relevant MeSH terms:
Charcoal
Phenytoin
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014