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
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: 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 September 30, 2014