EUCTR2017-000320-10-Outside-EU/EEA进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Dose-Controlled, Multicenter Study Evaluatingthe Safety and Efficacy of Dexmedetomidine in Intubated and Mechanically Ventilated Pediatric IntensiveCare Unit Subjects
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hospira Inc
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Initially intubated and mechanically ventilated pediatric subjects (=1 month (birth age corrected for
- •prematurity) to <17 years of age) in an intensive care setting. The means by which the subject
- •was intubated could include nasotracheal, endotracheal or via tracheotomy. The subject must
- •have been mechanically ventilated prior to and during the commencement of study drug.
- •2. Anticipated to require a minimum of 6 hours of continuous intravenous (IV) sedation.
- •3. American Association of Anesthesiologists (ASA) classification of 1, 2, 3, or 4.
- •4. A UMSS score of 1, 2, 3, or 4 at the start of infusion of study drug.
- •5. A dose had been established for this subject's age based upon Table 1.
- •6. If female, subject was non-lactating and was either:
- •a. Not of childbearing potential, defined as pre-menarche, or surgically sterile due to
- •bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- •b. Of childbearing potential but was not pregnant at time of baseline.
- •7. Subject's parent(s) or legally acceptable representative had/have voluntarily signed and dated the
- •informed consent document approved by the Institutional Review Board (IRB). Assent was
- •obtained where age-appropriate and according to state regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 175
- •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
排除标准
- •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
- •Age 1 month to =6 months old: systolic BP (SBP) <60 mmHg
- •Age >6 months to <2 years old: SBP <70 mmHg
- •Age >2 to <12 years old: SBP <80 mmHg
- •Age >12 to <17 years old: SBP <90 mmHg
- •5. Pre-existing bradycardia that persisted beyond a 15-minute period of re-assessment prior to
- •starting study drug:
- •Age 1 month to <2 months old: HR <90 beats per minute (bpm)
- •Age =2 months to <12 months old: HR <80 bpm
- •Age =12 months to <2 years old: HR <70 bpm
- •Age =2 to <12 years old: HR <60 bpm
- •Age =12 to <17 yrs old: HR <50 bpm
- •6. Alanine aminotransferase (ALT/ serum glutamic-pyruvic transaminase [SGPT]):
- •1 month to 12 months old: >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
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