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Phenytoin and Multidose Activated Charcoal

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00823264
First received: January 14, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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 shorten the half-life of phenytoin in the blood.


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:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Serum Phenytoin 1/2 life. [ Time Frame: Every hours initially then once a day ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: August 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive multiple doses of activated charcoal
 Drug: Activated Charcoal
50 grams by mouth every 4 hours until serum phenytoin level is less than 25.
No Intervention: 2
Will not receive activated charcoal. Serum levels will be followed.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823264

Contacts
Contact: Carl Skinner, MD 404-230-8953 cskinne@emory.edu
Contact: Brent Morgan, MD 404-230-8953 bmorg02@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Skinner         cskinne@emory.edu    
Principal Investigator: Carl G Skinner, MD            
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Carl Skinner, MD Emory University
  More Information

No publications provided

Responsible Party: Carl Skinner, Georgia Poison Center/Emory University
ClinicalTrials.gov Identifier: NCT00823264     History of Changes
Other Study ID Numbers: IRB00008017
Study First Received: January 14, 2009
Last Updated: January 14, 2009
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

ClinicalTrials.gov processed this record on May 23, 2013