A Pharmacokinetic Study of Dexmedetomine in Infants

Phase 1

Completed

• Conditions: Cardiac Surgical Procedures

• Registration Number: NCT00459082
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-05
• Study Completion: 2006-11
• Status Verified: 2007-04
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-10
• Last Update Submitted: 2007-04-10
• Study First Posted: 2007-04-11
• Last Update Posted: 2007-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States