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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.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | No Intervention | Will not receive activated charcoal. Serum levels will be followed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Charcoal | Drug | 50 grams by mouth every 4 hours until serum phenytoin level is less than 25. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Skinner, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22897408 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Will not receive activated charcoal. Serum levels will be followed. |
| FG001 | Multiple Doses of Activated Charcoal | Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Will not receive activated charcoal. Serum levels will be followed. |
| BG001 | Multiple Doses of Activated Charcoal | Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | hours | Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours |
|
Participants were followed for the duration of hospital stay, an average of 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multiple Doses of Charcoal | Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brent Morgan | Emory University | 404-616-4403 | bmorg02@emory.edu |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc. |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control | Will not receive activated charcoal. Serum levels will be followed. | 0 | 8 | 0 | 8 |
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