A Pharmacokinetic Study of Dexmedetomine in Infants

NCT00459082 | Completed Phase 1

• 1 other identifier: PPRU 10760
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgical Procedures

Keywords

Dexmedetomine; Post-operative cardiac surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Interventions

Dexmedetomine DRUG

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: May 1, 2004
• Study Completion: November 1, 2006
• Last Updated: April 11, 2007

Record last verified: 2007-04

Locations

US (1)