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

This study has been terminated.
(Difficulty recruiting subjects)
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00219479
First received: September 15, 2005
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Dilantin levels

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219479

Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Sandralee A Blosser, MD Penn State University
  More Information

No publications provided

Responsible Party: Sandralee Blosser, MD, Penn State Hershey
ClinicalTrials.gov Identifier: NCT00219479     History of Changes
Other Study ID Numbers: IRB #96-264
Study First Received: September 15, 2005
Last Updated: June 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
seizure prophylaxis
enteral nutrition

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Phenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014