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| Tracking Information | |||||
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| First Received Date ICMJE | September 15, 2005 | ||||
| Last Updated Date | June 13, 2008 | ||||
| Start Date ICMJE | August 1997 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Dilantin levels | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00219479 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study | ||||
| Official Title ICMJE | Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study | ||||
| Brief Summary | It is unclear how enteral nutrition via a feeding tube should be given when a patient is receiving enteral Dilantin. Some caregivers hold the feedings for one hour before and one hour after the Dilantin dose to insure adequate absorption of the medication and some caregivers think that the feedings do not need to be interrupted. Hypothesis: Dilantin levels will remain therapeutic when enteral nutrition is given continuously during the administration of enteral Dilantin. The objective of this study is to determine Dilantin levels when enteral feedings are given by the continuous method. Thirty patients will be studied. When Dilantin levels are in the therapeutic range for 2 consecutive days on interrupted feedings (baseline), the patient will be switched to continuous feedings uninterrupted for the medication, for 7 days. Dilantin levels will be checked daily and if the levels become subtherapeutic an intravenous (IV) bolus of Dilantin will be given and the enteral dose will be increased (doses determined by primary caregiver). Serum albumin will be measured at baseline and at the beginning and end of each week, in order to calculate free Dilantin. |
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| Detailed Description | Rationale: It is unclear how enteral nutrition via feeding tube should be given when a patient is receiving enteral Dilantin. Some caregivers hold the feedings for one hour before and one hour after the Dilantin dose to insure adequate absorption of the medication and some caregivers think that the feedings do not need to be interrupted. Both methods are used in this institution, although the interrupted method is recommended by the Clinical Nutrition Service. Interrupting the feedings has the obvious disadvantage that the patient receives less hours of feeding and requires more nursing intervention. Key Objectives: To determine the change in Dilantin levels when enteral feedings are given by the continuous method. Study Population: 30 patients already on Dilantin for seizure prophylaxis who are already receiving enteral nutrition by the interrupted method and have stable, therapeutic Dilantin levels. Major Inclusion Criteria:
Major Exclusion Criteria:
Allocation to Groups: all patients will be switched from baseline method of feeding (interrupted) to continuous feeding. Procedures: When Dilantin levels are in the therapeutic range for 2 consecutive days on interrupted feedings (baseline), the patient will be switched to continuous feedings uninterrupted for the medication, for 7 days. Dilantin levels will be checked daily and if the levels become subtherapeutic an IV bolus of Dilantin will be given and the enteral dose will be increased (doses determined by primary caregiver). Serum albumin will be measured at baseline and at the beginning and end of each week, in order to calculate free Dilantin. Risks and Discomforts:
Confidentiality: Subjects will be identified only by initials and study number. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Bio-availability Study | ||||
| Condition ICMJE | Seizures | ||||
| Intervention ICMJE | Drug: Phenytoin (Dilantin) levels during change in enteral feeding | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 3 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00219479 | ||||
| Responsible Party | Sandralee Blosser, MD, Penn State Hershey | ||||
| Study ID Numbers ICMJE | IRB #96-264 | ||||
| Study Sponsor ICMJE | Penn State University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Penn State University | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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