Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Penn State University |
---|---|
Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00219479 |
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.
Condition | Intervention | Phase |
---|---|---|
Seizures |
Drug: Phenytoin (Dilantin) levels during change in enteral feeding |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Bio-availability Study |
Official Title: | Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study |
Enrollment: | 3 |
Study Start Date: | August 1997 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Penn State Hershey ( Sandralee Blosser, MD ) |
Study ID Numbers: | IRB #96-264 |
Study First Received: | September 15, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00219479 History of Changes |
Health Authority: | United States: Institutional Review Board |
seizure prophylaxis enteral nutrition |
Phenytoin Signs and Symptoms Epilepsy Seizures |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Anticonvulsants |
Phenytoin Signs and Symptoms Epilepsy Therapeutic Uses Nervous System Diseases Seizures |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |