EUCTR2013-003105-25-FI进行中（未招募）不适用
The prophylactic effect of levosimendan in reducing acute kidney injury postoperatively in pediatric patients undergoing corrective heart surgery - Renal protection effect of levosimendan in pediatric congenital heart surgery
Sahlgrenska University Hospital / The Queen Silvia Children´s Hospital0 个研究点目标入组 70 人开始时间: 2014年12月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provision of informed consent prior to any study specific procedures
- •2.Female and male children between 1 and 12 months of age
- •3.Non-restrictive VSD (corrective surgery)
- •4.Complete AVSD (biventricular repair)
- •5.Tetralogy of Fallot
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Unbalanced AVSD
- •2.Age less than one month and more than one year
- •3.acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
- •4.Pre-existing renal disease
- •5.Liver impairment or disease
- •6.Infection
- •7.Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day
- •8.Allergy to Levosimendan or previous use of it,
- •9.Severe arrhythmias needing pace-maker treatment prior to the operation
- •10.Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation
- •11.Severe uncorrected hypotension where the initiation of anesthesia is postponed for its correction
- •12.Re-operation
研究者
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