Dexmedetomidine pharmacokinetics-pharmacodynamicsin mechanically ventilated neonates with single-organ respiratory failure

Phase 1

• Conditions: Patients admitted to the neonatal intensive care unit with single-organ respiratory failure; MedDRA version: 18.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2010-023155-28-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- patient age less than 1 month (adaptive design:step-down strategy for age)
- patients with single-organ respiratory failure in need for analgosedation (guidance : Comfort neo score>14 or Numeric Rating Scale (NRS) score Pain (P)/Comfort (C)>4)
- patients admitted to the neonatal intensive care or cardiac intensive care unit
- expected to require at least 20 h of mechanical ventilation

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
- no arterial catheter in place at inclusion
- patients who have received another investigational drug within 30 days
- patients on continuous infusion with neuromuscular blockers
- patients with a life expectancy <72h
- patients with a known allergy to fentanyl
- congenital or acquired heart block (grade 3)
- sustained bradycardia
- haemodynamically unstable patients (definition : Mean Arterial Pressure (MAP) lower than : gestational age (in weeks) – (absolute minimum for cardiac surgery patients: 40 mm Hg), eventually under dopamine infusion max. 15 mcg/kg/min and/or dobutamine infusion max. 15 mcg/kg/min) and/or epinephrine infusion: max 0,2 mcg/kg/min. More stringent criteria can be used based on an individual basis at the discretion of the attending neonatologist/intensivist.
- patients with significant renal insufficiency (creatinine plasma level >1.5 mg/dl)
- patients with significant hepatic insufficiency (as estimated by local investigators)
- previous treatment with a2-adrenoreceptor agonist clonidine within 14 days
- absence of parental consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified