EUCTR2017-000407-24-Outside-EU/EEA进行中（未招募）1 期
A Phase II, Randomized, Open-Label, Single Center, Pharmacokinetic andPharmacodynamic Study of Dexmedetomidine in Pediatric Subjects Aged12 months through <24 months
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
- 6
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
- •Subject is 12 months to < 24 months of age at screening.
- •2. Subject is intubated and mechanically ventilated in an intensive care setting and is
- •anticipated to require a minimum of 6 hours of continuous IV sedation.
- •3. Subject has adequate renal function, defined as:
- •Serum creatinine = 1.0 mg/dL
- •4. The subject’s parent(s) or legal guardian(s) must voluntarily sign and date the
- •informed consent document approved by the Institutional Review Board.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •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 prohibit an evaluation of
- •sedation such as:
- •Diminished consciousness from increased intracranial pressure
- •Extensive brain surgery (surgery requiring intracranial pressure monitor)
- •Diminished cognitive function per Principal Investigator (PI) discretion
- •Subjects with immobility from neuromuscular disease or continuous infusion
- •of neuromuscular blocking agents.
- •2. Subjects with second degree or third degree heart block unless subject has a
- •permanent pacemaker or pacing wires are in situ.
- •3. Subjects who have hepatic impairment as defined by a SGPT/ALT >90 U/L at the
- •time of Screening.
- •4. Subjects who have hypotension, based on repeat assessments within 15 minutes
- •preceding the start of study drug, defined as:
- •SBP < 70 mmHg
- •5. Pre-existing bradycardia based on repeated assessments within 15 minutes
- •preceding the start of study drug, defined as:
- •HR < 70 bpm
- •6. Subject who have acute thermal burns involving more than 15 percent total body
- •surface area.
- •7. Subjects who have a known allergy to dexmedetomidine, MDZ or fentanyl.
- •8. Subject who has received dexmedetomidine within 24 hours prior to the start of
- •study drug.
- •9. Subjects with a life expectancy that is < 72 hours.
- •10. Subjects that are expected to have hemodialysis (continuous hemofiltration),
- •peritoneal dialysis or extracorporeal membrane oxygenation (ECMO) treatments
- •within 48 hours prior to the start of study drug or during the duration of the study.
- •11. Subjects who have been treated with a-2 agonists/antagonists within two weeks
- •(see Appendix B).
- •12. Subjects with a spinal cord injury above T5.
- •13. Subjects who have received another investigational drug as part of an
- •investigational drug study within the past 30 days.
- •14. Subjects who, in the opinion of the investigator, may not be able to comply with
- •the safety monitoring requirements of this clinical study.
研究者
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