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Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study

Primary Purpose

Seizures

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Phenytoin (Dilantin) levels during change in enteral feeding
Sponsored by
Penn State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring seizure prophylaxis, enteral nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: On Dilantin for seizure prophylaxis (dose determined by primary caregiver) with therapeutic Dilantin levels Receiving enteral nutrition by the interrupted method at goal feeding rate Age >18 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: History of seizures Albumin infusions necessary during study period Anticipation that feedings will need to be held for more than 4 hours at a time Patients that do not maintain stable Dilantin levels (< 25% variability) with the interrupted method of feeding Inability to obtain consent from patient or spokesperson

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Dilantin levels

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2005
    Last Updated
    November 21, 2017
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00219479
    Brief Title
    Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study
    Official Title
    Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Difficulty recruiting subjects
    Study Start Date
    August 1997 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Penn State University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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: on Dilantin for seizure prophylaxis (dose determined by primary caregiver) with therapeutic Dilantin levels receiving enteral nutrition by the interrupted method at goal feeding rate; age >18 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: history of seizures albumin infusions necessary during study period anticipation that feedings will need to be held for more than 4 hours at a time 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: subtherapeutic Dilantin levels, but these will be closely followed; seizures, patient will be discontinued if this occurs; 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seizures
    Keywords
    seizure prophylaxis, enteral nutrition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Phenytoin (Dilantin) levels during change in enteral feeding
    Primary Outcome Measure Information:
    Title
    Dilantin levels

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: On Dilantin for seizure prophylaxis (dose determined by primary caregiver) with therapeutic Dilantin levels Receiving enteral nutrition by the interrupted method at goal feeding rate Age >18 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: History of seizures Albumin infusions necessary during study period Anticipation that feedings will need to be held for more than 4 hours at a time Patients that do not maintain stable Dilantin levels (< 25% variability) with the interrupted method of feeding Inability to obtain consent from patient or spokesperson
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandralee A Blosser, MD
    Organizational Affiliation
    Penn State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study

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