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Trial record 6 of 107 for:    PHENYTOIN

Phenytoin and Multidose Activated Charcoal

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ClinicalTrials.gov Identifier: NCT00823264
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Brent W Morgan, MD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Phenytoin Toxicity
Intervention Drug: Activated Charcoal
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Multiple Doses of Activated Charcoal
Hide Arm/Group Description Will not receive activated charcoal. Serum levels will be followed. Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.
Period Title: Overall Study
Started 10 7
Completed 8 7
Not Completed 2 0
Reason Not Completed
Protocol Violation             2             0
Arm/Group Title Control Multiple Doses of Activated Charcoal Total
Hide Arm/Group Description Will not receive activated charcoal. Serum levels will be followed. Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc. Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  87.5%
7
 100.0%
14
  93.3%
>=65 years
1
  12.5%
0
   0.0%
1
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
7
 100.0%
15
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 15 participants
8 7 15
1.Primary Outcome
Title Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Multiple Doses of Activated Charcoal
Hide Arm/Group Description:
Will not receive activated charcoal. Serum levels will be followed.
Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
Overall Number of Participants Analyzed 8 7
Median (Inter-Quartile Range)
Unit of Measure: hours
41.1
(11.6 to 196)
19.3
(13 to 33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Multiple Doses of Activated Charcoal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Participants were followed for the duration of hospital stay, an average of 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multiple Doses of Charcoal Control
Hide Arm/Group Description Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc. Will not receive activated charcoal. Serum levels will be followed.
All-Cause Mortality
Multiple Doses of Charcoal Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Multiple Doses of Charcoal Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multiple Doses of Charcoal Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brent Morgan
Organization: Emory University
Phone: 404-616-4403
EMail: bmorg02@emory.edu
Layout table for additonal information
Responsible Party: Brent W Morgan, MD, Emory University
ClinicalTrials.gov Identifier: NCT00823264     History of Changes
Other Study ID Numbers: IRB00008017
First Submitted: January 14, 2009
First Posted: January 15, 2009
Results First Submitted: August 14, 2013
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014