A Pharmacokinetic Study of Dexmedetomine in Infants

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00459082
First received: April 9, 2007
Last updated: April 10, 2007
Last verified: April 2007
  Purpose

Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.


Condition Intervention Phase
Cardiac Surgical Procedures
Drug: Dexmedetomine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of Dexmedetomine in Infants

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Pharmacodynamics: vital signs, cardiac rhythm, oxygen saturation, laboratory evaluations and adverse events will be monitored to determine the safety of dexmedetomine.
  • Pharmacokinetics: will measure plasma concentrations for dose escalations of dexmedetomine to determine the maximum tolerated dose (MTD).

Secondary Outcome Measures:
  • Pharmacodynamics: The Bispectral Index Scale(BIS) and the University of Michigan sedation scale will be used to measure the level of sedation and dexmedetomine plasma drug concentrations.
  • Pharmacogenetics: will examine the relationship between genotype, drug exposure and drug response in infants postoperative form cardiac surgery.

Estimated Enrollment: 36
Study Start Date: May 2004
Estimated Study Completion Date: November 2006
Detailed Description:

This clinical trial of three dose rates of dexmedetomine will determine the pharmacokinetics of the drug in infants who remain tracheally intubated postoperatively. An exploratory pharmacodynamic study of a non-invasive device measuring sedation will be performed. Although the pharmacokinetics of dexmedetomine have been described for pediatric patients, the drug disposition in infants has not been well described. A range of doses has been studied, yet there are no reports describing the optimal dose for post-operative pediatric patients. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than or equal to 1 month, less than or equal to 24 months
  • Post-operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-operative period
  • Planned tracheal extubation within 24 hours post-operative period
  • Renal function-serum creatine = 1.5 times the ULN for age
  • Total bilirubin less than or equal to 1.5 X upper limit of normal (ULN) for age
  • SGPT (ALT) ,less than+ 3x upper limit of normal (ULN) for age
  • Signed written informed consent

Exclusion Criteria:

  • Patients who have received another investigational drug within the past 30 days
  • Receiving intermittent or continuous muscle relaxation during study period
  • Patients who have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
  • Post-Operative hypotension
  • Heart block
  • Weight < 5 kg
  • Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459082

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00459082     History of Changes
Other Study ID Numbers: PPRU 10760
Study First Received: April 9, 2007
Last Updated: April 10, 2007
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Dexmedetomine
Post-operative cardiac surgery

ClinicalTrials.gov processed this record on April 14, 2014