Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Mean total urine output production in the first post-operative day
研究概览
简要总结
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
详细描述
Diuretic therapy in children after open heart surgery is widely administered, though no evidence currently supports if an ideal drug or an ideal dosage can be recommended. Loop diuretics are the most effective drugs in terms of urine output production but may cause some collateral effects such as metabolic alkalosis, hypovolemia, hypokalemia, ototoxicity. Furthermore, some reports showed that loop diuretics usage can be associated with an increased risk of renal dysfunction and mortality. However, their use in children with signs of fluid overload, pulmonary edema or oliguria is mandatory and widely practiced.
Furosemide and ethacrynic acid are often prescribed and administered without any specific indication, basing on clinicians preferences.
No study so far, explored the hypothesis of which of these drugs is the most effective in terms of urine output production and safe in terms of renal function.
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
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
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with congenital heart disease undergoing cardiac surgery
- •intraoperative aortic cross clamp over 90 minutes or interventional catheterization procedures with post-operative inotrope score over 20
- •sign of fluid retention after surgical procedures
排除标准
- •Preoperative renal dysfunction
- •Preoperative administration of more than 4mg/kg/die loop diuretics
- •Need for renal replacement therapy at ICU admission
- •Need for ECMO at ICU admission
研究组 & 干预措施
furosemide
furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours
干预措施: furosemide (Drug)
ethacryinic acid
ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours
干预措施: ethacrynic acid (Drug)
结局指标
主要结局
Mean total urine output production in the first post-operative day
时间窗: first 24 hours after Intensive Care Unit admission
Verification of the superiority of ethacrynic acid compared with furosemide in improving patients' total urine output by at least 1 ml/kg/h in the first 24 post-operative hours
次要结局
- Mean creatinine and NGAL values(first 72 hours after Intensive Care Unit admission)
研究者
Zaccaria Ricci
Medical Doctor, Research Fellow
Bambino Gesù Hospital and Research Institute