Initially intubated and mechanically ventilated pediatric subjects in ICU setting
Conditions
Interventions
Trade Name: Precedex
Product Name: dexmedetomidine HCl
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Hospira Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Initially intubated and mechanically ventilated pediatric subjects (=1 month (birth age corrected for prematurity) to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pediatric subjects with neurological conditions that prohibited an evaluation of sedation in the opinion of the Investigator (e.g., increased intracranial pressure or extensive brain surgery). 2. The infusion pump minimal capacity could not accommodate the lowest possible maintenance infusion rate of study drug based on subject's weight. 3. Subjects with second degree or third degree heart block unless subject had a pacemaker or pacing wires. 4. Hypotension that persisted beyond a 15-minute period of re-assessment prior to starting study drug:12 • Age 1 month to =6 months old: systolic BP (SBP) 6 months to 2 to 12 to 165 units/liter (U/L) • >12 months to <17 years old: =100U/L Note: Subjects could be re-screened up to 6 hours prior to study drug infusion (not including subjects undergoing cardiac surgery with CPB). 7. Subjects had a known allergy to DEX, MDZ, morphine, or fentanyl. 8. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain control.Subjects with immobility from neuromuscular disease, paralysis from administration of neuromuscular blocking (NMB) agents, spinal cord injury above T5 or subjects with muscle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects, to evaluate the safety an efficacy of loading and maintenance infusions for sedation on initially intubated and mechanically ventilated pediatric intensive care unit subjects and to explore the exposure-response relationship between dose of DEX and clinical neasures of sedation and safety;Secondary Objective: Not applicable;Primary end point(s): The percent of subjects that do not require rescue MDZ for sedation based on achieving and maintaining a target UMSS score of 1 to 3 while intubated;Timepoint(s) of evaluation of this end point: continuous infusion of DEX must be at least 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints included the absolute time and percentage of time on study drug that the subject is in a UMSS score range of 1 to 3 while intubated; absolute time and percentage of time on study drug that the subject was out of the target sedation range while intubated (UMSS score of 0 or 4); total amount of rescue medication required for sedation and analgesia; time to first dose of rescue medication for sedation and analgesia; and time to extubation.;Timepoint(s) of evaluation of this end point: until extubation | — |
Countries
United States
Contacts
Public ContactGlobal Clinical R&D and Medical Aff
Hospira Inc
Outcome results
None listed