Trial Outcomes & Findings for Phenytoin and Multidose Activated Charcoal (NCT NCT00823264)
NCT ID: NCT00823264
Last Updated: 2014-09-11
Results Overview
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.
COMPLETED
NA
17 participants
Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours
2014-09-11
Participant Flow
Participant milestones
| Measure |
Control
Will not receive activated charcoal. Serum levels will be followed.
|
Multiple Doses of Activated Charcoal
Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is \< 25 ug/cc.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Control
Will not receive activated charcoal. Serum levels will be followed.
|
Multiple Doses of Activated Charcoal
Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is \< 25 ug/cc.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Phenytoin and Multidose Activated Charcoal
Baseline characteristics by cohort
| Measure |
Control
n=8 Participants
Will not receive activated charcoal. Serum levels will be followed.
|
Multiple Doses of Activated Charcoal
n=7 Participants
Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are \< 25 ug/cc.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hoursWe 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.
Outcome measures
| Measure |
Control
n=8 Participants
Will not receive activated charcoal. Serum levels will be followed.
|
Multiple Doses of Activated Charcoal
n=7 Participants
Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
|
|---|---|---|
|
Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels
|
41.1 hours
Interval 11.6 to 196.0
|
19.3 hours
Interval 13.0 to 33.0
|
Adverse Events
Multiple Doses of Charcoal
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place