Phenytoin and Multidose Activated Charcoal

NCT00823264 | Completed Results

• 1 other identifier: IRB00008017
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Phenytoin Toxicity

Keywords

Anticonvulsants; Toxicology; multidose charcoal; phenytoin

Outcome Measures

Primary Outcomes (1)

• Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels

  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

Study Arms (2)

Multiple Doses of Activated Charcoal

EXPERIMENTAL

Patients will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels drop below 25 ug/cc

Drug: Activated Charcoal

Control

NO INTERVENTION

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

Interventions

Activated Charcoal DRUG

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

Also known as: Charcoal

Multiple Doses of Activated Charcoal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phenytoin level \> 30 mg/L

You may not qualify if:

• Age \< 18
• Known allergy to Activated Charcoal
• Pregnant
• Inability to take PO drugs
• Non English speaking
• Inability to give consent
• Any prisoners

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• 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.

  PMID: 22897408 RESULT

MeSH Terms

Interventions

Charcoal

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Results Point of Contact

• Title: Dr. Brent Morgan
• Organization: Emory University

bmorg02@emory.edu

404-616-4403

Study Officials

• Carl Skinner, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2012
• Last Updated: September 11, 2014
• Results First Posted: September 11, 2014

Record last verified: 2014-09

Locations

US (1)