Phase 4, Open-Label Study Evaluating the Hemodynamic Effect of Differing Loading Regimens of Precedex in a Post-Surgical Intensive Care Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 373
- 试验地点
- 15
- 主要终点
- Incidence of clinically meaningful hemodynamic abnormality (CMHA)
研究概览
简要总结
The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an intensive care setting.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
- •Initially intubated and mechanically ventilated adult post-operative subjects in an intensive care setting (e.g., post operative care unit, post anesthesia care unit, etc.) that are expected to require sedation for at least 2 hours.
- •Has an American Society of Anesthesiologist (ASA) classification of 1, 2, 3 or
- •ASA Physical Status Classification System
- •P1 A normal healthy subject
- •P2 A subject with mild systemic disease
- •P3 A subject with severe systemic disease
- •P4 A subject with severe systemic disease that is a constant threat to life
- •P5 A moribund subject who is not expected to survive without the operation
- •P6 A declared brain-dead subject whose organs are being removed for donor purposes.
- •If female, subject must be postmenopausal, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
- •hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
- •intrauterine device (IUD)
- •double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
排除标准
- •Subjects <18 years of age.
- •Subjects with a 2nd degree Mobitz Type II or 3rd degree heart block, unless the subject has a permanent pacemaker or pacing wires are in situ.
- •Subjects with a known allergy to dexmedetomidine.
- •Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP <90 mmHg or Diastolic BP <60 mmHg.
- •Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR <50 bpm.
- •Subjects who, in the opinion of the Investigator, have any other condition where the risks of dexmedetomidine would be expected to outweigh its benefits (e.g., cardiogenic shock on >2 vasopressors, death anticipated within 48 hours).
研究组 & 干预措施
Group I - No loading dose
No loading dose to be administered during the loading-dose paradigms
干预措施: Dexmedetomidine (Drug)
Group II - Loading dose over 10 minutes
Loading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms
干预措施: Dexmedetomidine (Drug)
Group III - Loading dose over 20 minutes
Loading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of clinically meaningful hemodynamic abnormality (CMHA)
时间窗: During the first 2 hours of study drug administration
Clinically meaningful hemodynamic abnormalities (CMHA) consist of (any): * Heart Rate (HR): A native HR \<40 bpm (beats per minute); HR \<50 bpm requiring pharmacological intervention; systolic BP \<80 mm Hg; if pacing wires are in situ, use of a pacemaker after the start of study drug. * Vasoactive Agent Use (i.e. vasopressor or inotrope): the need to add an additional agent to maintain BP; doubling of the dose of any vasoactive agent that was infusing at the start of the study drug. * Paradoxical hypertension: the need to add an additional vasodilating agent for control of hypertension; doubling of the dose of any vasodilating agent that was infusing at the start of the study drug.
次要结局
- Incidence of paradoxical hypertension(Post-dexmedetomidine 24-hour observation period)
- Amount of analgesics administered(2 hours prior, and for the first 2 hours during, study drug administration)
- Amount of sedatives administered(2 hours prior, and for the first 2 hours during, study drug administration)
- Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.(Maintenance infusion period (2 to 24 hours))
- Incidence of adverse events (AEs) between the 3 loading-dose paradigms(Post-dexmedetomidine 24-hour observation period)