ACTRN12609000899246尚未招募未知
The Effects of Dobutamine and Levosimendan in High Risk Cardiac Surgery Patients
Intensive Care Research Fund0 个研究点目标入组 60 人开始时间: 2009年10月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients presenting for Coronary artery bypass grafting or valve surgery or both.Documented pre operative left ventricular ejection fraction = 30 % or moderate to severe Left Ventricular Failure (echo finding).Willingness to give written informed consent and willingness to participate and comply with the study.
排除标准
- •Patients who have received Levosimendan in the past 2 weeks.Patients who are moribund and not expected to survive. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.Patients with established renal failure ( Glomerular Filtration Rate <30 % +/- dialysis ).Patients who weigh >150 kg.Patients aged <18 years.Patients undergoing salvage surgery.Patients with a known or suspected infection and who also have 2 or more systemic inflammatory response syndrome criteria who are on high dose vasopressors (High dose vasopressors Noradrenaline >0.2 mcg/kg/min or Dobutamine >10 mcg/kg/min).Patients with cardiogenic shock due to an untreated mechanical cause ie pulmonary embolism, tamponade, acute valve disease . Patients with a known or suspected allergy to the study drugs.Cardiogenic shock unresponsive to high dose vasopressors (Noradrenaline >0.2 mcg/kg/min or Dobutamine >10 mcg/kg/min) persistant mean arterial pressure< 60 mmHG or systolic blood pressure < 80 mmHg.Congenital Heart disease or acquired structural cardiac defect eg ventricular septal defect. Administration of Milronone within 24 hours before the start of Levosimendan infusion.Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
- •History of Torsades de pointes.Uncorrected serum potassium levels <3.5mmols/L or >4.5mmols/L.Patients who appear to be responding adequately to standard therapy
- •.Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease and restricted or hypertrophic cardiomyopathy.
研究者
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