Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- BOIRON
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Amount of drained liquid from the mediastinum or the pleura
研究概览
简要总结
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a pilot study; a confirmative study will be set up if this study is positive.
The study treatment will start the day before surgery, and will comprise 5 granules of each homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5 days, in addition to all routine treatments.) Two groups of 45 patients will be included. Patients have to be over 18 years, to undergo aortic valve surgery only, have no known allergy to one of the study drugs, sign a consent form, and must not have received anti inflammatory drug in the 3 days before surgery. The primary criteria include the amount of drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up phone call is given to the patients 30 days after their surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation
排除标准
- •acute infectious or inflammatory concomitant disease, known allergy to one of the investigational products, Patients who did not sign the study consent form, patients having received during the 3 days before surgery any corticoids or non steroid anti-inflammatory drug, patient undergoing a surgery other than surgery of the aortic valve in the same intervention, patient undergoing an iterative cardiac surgery, patients under 18 years, patient over 18 years under the protection of the law.
研究组 & 干预措施
1
Arnica 5CH and Bryonia 9CH (homeopathic drugs)
干预措施: Arnica and Bryonia (Drug)
2
placebo Arnica 5CH and Bryonia 9CH
干预措施: placebo (Drug)
结局指标
主要结局
Amount of drained liquid from the mediastinum or the pleura
时间窗: At drain removal
plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)
时间窗: Day 2 and Day 7
次要结局
- Evolution of body temperature from before surgery to day 2 after surgery.(Day 2)
- Time from the end of extra corporeal circulation to closure of the thorax,(Closure of thorax)
- Amount of transfusions of erythrocytes, platelets, plasma.(Day 7)
- Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,(To day 7)
- Amount of analgesic drugs, paracetamol and morphine.(Day 7)
- EKG before surgery, 24 and 48 hours after surgery.(48 hours)
- Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.(48 hours)
- Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.(Day 7)
- Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery.(30 days)