A Phase II, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study to Assess the Pharmacokinetics and Pharmacodynamics of MTR105 in Cardiac Surgery Induced Hypotension Patients During Weaning Off Cardiopulmonary Bypass
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hemodynamic parameters
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.
详细描述
The study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of MTR105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Men or women age 18 years or older
- •Referred for cardiac surgery requiring the use of CPB.
- •Elective or urgent surgeries (non emergency operations).
- •LVEF ≥40 based on cardiac catheterization results
- •Normal renal function at study entry
- •Normal hepatic function (within normal laboratory ranges) at study entry
- •Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.
- •Willingness to participate in the study and adhere to the study design.
- •Willingness to sign an informed consent form.
排除标准
- •Emergency operation
- •Pulmonary hypertension (PA systolic pressure >60 mmHg)
- •Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8
- •Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery
- •Body weight <40 Kg
- •Pregnancy
- •Malignancy within 1 year of presenting for surgery
- •Systemic infection as evidenced by elevated WBC or fever >38.5 C
- •Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.
- •Participation in any other investigational drug or device study within 30 days of randomization
研究组 & 干预措施
1
Dose level 0.3 mg/kg with 6 active and 2 placebo
干预措施: MTR105 (Drug)
2
Dose level 0.6 mg/kg 6 patients active and 2 placebo
干预措施: MTR105 (Drug)
3
Dose level 1.2 mg/kg 6 active and 2 placebo
干预措施: MTR105 (Drug)
4
Dose level 2.4 mg/kg 6 active and 2 placebo
干预措施: MTR105 (Drug)
结局指标
主要结局
Hemodynamic parameters
时间窗: 24 hours
次要结局
- Pharmacokinetics(10 hours)