Phenytoin Toxicity
Conditions
Keywords
Anticonvulsants, Toxicology, multidose charcoal, phenytoin
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.
Detailed description
See above
Interventions
50 grams by mouth every 4 hours until serum phenytoin level is less than 25.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Will not receive activated charcoal. Serum levels will be followed. | 8 |
| Multiple Doses of Activated Charcoal Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are \< 25 ug/cc. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Control | Multiple Doses of Activated Charcoal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
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.
Time frame: Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels | 41.1 hours |
| Multiple Doses of Activated Charcoal | Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels | 19.3 hours |
p-value: 0.049Wilcoxon (Mann-Whitney)