- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823264
Phenytoin and Multidose Activated Charcoal
September 4, 2014 updated by: Brent W Morgan, MD, Emory University
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.
Study Overview
Detailed Description
See above
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
50 grams by mouth every 4 hours until serum phenytoin level is less than 25.
Other Names:
|
No Intervention: Control
Will not receive activated charcoal.
Serum levels will be followed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carl Skinner, MD, Emory University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
January 14, 2009
First Submitted That Met QC Criteria
January 14, 2009
First Posted (Estimate)
January 15, 2009
Study Record Updates
Last Update Posted (Estimate)
September 11, 2014
Last Update Submitted That Met QC Criteria
September 4, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00008017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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