Phenytoin and Multidose Activated Charcoal

NCT ID: NCT00823264

Last Updated: 2014-09-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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See above

Conditions

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Phenytoin Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Activated Charcoal

Intervention Type DRUG

50 grams by mouth every 4 hours until serum phenytoin level is less than 25.

Control

Will not receive activated charcoal. Serum levels will be followed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Activated Charcoal

50 grams by mouth every 4 hours until serum phenytoin level is less than 25.

Intervention Type DRUG

Other Intervention Names

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Charcoal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Brent W Morgan, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carl Skinner, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22897408 (View on PubMed)

Other Identifiers

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IRB00008017

Identifier Type: -

Identifier Source: org_study_id

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