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

NCT00219479 | Terminated Phase 4

• 1 other identifier: IRB #96-264
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seizures

Keywords

seizure prophylaxis; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• Dilantin levels

Interventions

Phenytoin (Dilantin) levels during change in enteral feeding DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

MeSH Terms

Conditions

Seizures

Interventions

Phenytoin; Enteral Nutrition

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Sandralee A Blosser, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 1997
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 24, 2017

Record last verified: 2017-11