NCT00927654已完成3 期
Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 6
- 主要终点
- Duration of post-operative artificial respiration after arrival on intensive care unit
研究概览
简要总结
In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis) before and during extracorporal circulation on perioperative morbidity and outcome in high risk cardiac surgical patients is investigated in comparison to placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •for females of childbearing potential: negative pregnancy test
- •patients, male or female, 18 to 85 years old
- •elective open-heart surgery using heart-lung-machine
- •patients with increased risk to suffer from perioperative right heart failure, i.e.,
- •protracted surgery: multiple valvular transplant or expected bypass time exceeding 120 min and/or
- •patients with preoperative known pulmonary hypertension and/or
- •patients with severe heart insufficiency (NYHA III or NYHA IV)
排除标准
- •patient not able to give consent
- •pregnant or nursing patients
- •Anamnestic known hypersensitivity to the used drug (Ventavis) and its ingredients or to drugs with a similar chemical structure
- •blood clotting disorder requiring treatment
- •trauma, intracerebral bleeding or apoplexy within the last 3 months prior to surgery
- •primary or secondary immune deficiency (e.g., pretreatment with steroids, cytostatics)
- •systemic infection
- •lung disorder with impaired gas exchange
- •lung transplantation
- •cardiac transplantation
- •implantation of LVAD (left ventricular assist device)
- •fluoride ulcus disorder
- •planned surgery in deep hypothermia and cardiac arrest
- •subconscious and psychiatric disordered patients
- •participation in another clinical trial within the last 30 days prior to study start and up to 30 days after end of study
- •previous participation in this study
研究组 & 干预措施
Iloprost
Experimental
干预措施: Iloprost (Ventavis) (Drug)
Isotonic Sodium Chloride solution 0.9 %
Placebo Comparator
干预措施: Isotonic Sodium Chloride solution 0.9 % (placebo) (Drug)
结局指标
主要结局
Duration of post-operative artificial respiration after arrival on intensive care unit
时间窗: 2-3 months
次要结局
- 90 days lethality(90 days)
研究者
Prof. Dr. med. B. Zwissler
Director Clinic for Anesthesiology
Ludwig-Maximilians - University of Munich
研究点 (6)
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