Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study
Information source: Penn State University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seizures
Intervention: Phenytoin (Dilantin) levels during change in enteral feeding (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Sandralee A Blosser, MD, Principal Investigator, Affiliation: Penn State University
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.
Clinical Details
Official title: Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Bio-availability Study
Primary outcome: Dilantin levels
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:
1. on Dilantin for seizure prophylaxis (dose determined by primary caregiver) with
therapeutic Dilantin levels
2. receiving enteral nutrition by the interrupted method at goal feeding rate;
3. age >18
4. feeding tube in proper position, no restriction as to type of feeding tube (nasogastric,
nasoduodenal, gastrostomy, jejunostomy), but both Dilantin and enteral feeding must be
given through the same tube.
Major Exclusion Criteria:
1. history of seizures
2. albumin infusions necessary during study period
3. anticipation that feedings will need to be held for more than 4 hours at a time
4. Patients that do not maintain stable Dilantin levels (< 25% variability) with the
interrupted method of feeding; 5) inability to obtain consent from patient or
spokesperson.
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:
1. subtherapeutic Dilantin levels, but these will be closely followed;
2. seizures, patient will be discontinued if this occurs;
3. venipuncture for 10 Dilantin levels and 3 serum albumin determinations (minimum blood
for each test is 0. 4 cc).
Confidentiality: Subjects will be identified only by initials and study number.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. On Dilantin for seizure prophylaxis (dose determined by primary caregiver) with
therapeutic Dilantin levels
2. Receiving enteral nutrition by the interrupted method at goal feeding rate
3. Age >18
4. Feeding tube in proper position, no restriction as to type of feeding tube
(nasogastric, nasoduodenal, gastrostomy, jejunostomy), but both Dilantin and enteral
feeding must be given through the same tube
Exclusion Criteria:
1. History of seizures
2. Albumin infusions necessary during study period
3. Anticipation that feedings will need to be held for more than 4 hours at a time
4. Patients that do not maintain stable Dilantin levels (< 25% variability) with the
interrupted method of feeding
5. Inability to obtain consent from patient or spokesperson
Locations and Contacts
Additional Information
Starting date: August 1997
Ending date: December 2007
Last updated: June 13, 2008
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