NCT02584868已完成3 期
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
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
- 88
- 试验地点
- 1
- 主要终点
- Calculated Blood Loss at 3rd Post Operative Day (POD)
研究概览
简要总结
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
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
- 28 Days 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 28 days to 3 years old
- •Planned cardiac surgery with cardiopulmonary by-pass
- •signed informed consent
排除标准
- •Moribund patients (ASA 5)
- •Jehovah Witnesses
- •Pre-operative coagulation disorders
- •Pre-operative renal insufficiency
- •Pre-operative hepatic disorders
- •Intra-cranial hemorrhage
- •hypernatremia
研究组 & 干预措施
Volulyte
Experimental
Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)
干预措施: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (Drug)
Voluven
Active Comparator
Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)
干预措施: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (Drug)
结局指标
主要结局
Calculated Blood Loss at 3rd Post Operative Day (POD)
时间窗: 72H post surgery
次要结局
- Creatinine(Post-operative Day 3)
- Total Blood Loss(72H post surgery)
- Exposure to Any Blood Products(72H post surgery)
- Exposure to Red Blood Cell(72H post surgery)
- Red Blood Cell Transfused(72H post surgery)
- Intraoperative Blood Loss(End of surgery, an average of 200 minutes)
- Fresh Frozen Plasma Transfused(72H post surgery)
- Clotting Time in Seconds(End of surgery, an average of 200 minutes)
- Maximal Cloth Firmness(End of surgery, an average of 200 minutes)
- Chest Tube Drainage(72H post surgery)
- Exposure to Fresh Frozen Plasma(72H post surgery)
- Exposure to Platelets(72H post surgery)
- Platelet Transfused(72H post surgery)
- C-Reactive Protein (CRP)(At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery))
- PTT(Post-operative Day 2)
- APTT(Post-operative Day 2)
- INR(Post-operative Day 2)
- Fibrinogen(Post-operative Day 2)
- CRP(Post-operative Day 3)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
VolulyteTM in Cardiac SurgeryDysfunction Postoperative, Cardiac Surgery HeartNCT01553617Fresenius Kabi133
已完成
不适用
Analgesic Efficacy of Bilateral US Guided TTPB vs ESPB in Pediatric Patients Undergoing Corrective Cardiac SurgeriesPain, PostoperativeNCT05559684Cairo University30
已完成
不适用
Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido CardioplegiaMyocardial InjuryNCT04051580Mahidol University200
进行中（未招募）
4 期
Comparison of balanced solutions in abdominal oncological surgery: a pragmatic, randomized, controlled, double-blind study between Plasmafundin and Ringer's LactateRBR-4h25ytkFundação Faculdade de Medicina
Unknown
不适用
The Effect of Fluids Flushed in Pediatric Cardiac Catheterization Procedures on Lung Ultrasound ScoreCongenital Heart DiseaseNCT04311918Cairo University43