A Randomized, Controlled Trial Evaluating Efficacy of Perioperative Organ Protection as Well as Safety of Ulinastatin Use in Pediatric Patients Undergoing Open Heart Surgery Through CPB to Treat Complex Congenital Heart Diseases
试验速览
- 阶段
- 4 期
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
研究概览
简要总结
- Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease
- Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay & cost
详细描述
Pediatric patients diagnosed with Complex Congenital Heart Disease ready to accept scheduled open-heart surgery under cardiopulmonary bypass (CPB).
This study uses randomized (centralized randomization) & controlled design with open label. Eligible subjects will be randomized to receive either study drug (Ulinastatin) or conventional treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Days 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with Complex Congenital Heart Disease .
- •Hospitalized children, both gender, aged ≥ 30 days to ≤ 4 years.
- •Preoperative assessment meet with surgical condition.
- •Without signs of Liver, Kidney, and Coagulatory dysfunction.
- •Written informed consent form has been signed by the Legal Guardian.
排除标准
- •Patients will accept minimally invasive surgery or palliative surgery, as well as Major Aortopulmonary Collateral Arteries (MAPCAs);
- •Its decided that subject needs to undergo second surgery in a short period of time, or underwent other major surgery.
- •Subjects with known hypersensitivity to study medication (Ulinastatin for Injection) or patients with highly allergic history.
- •Though meeting the study inclusion criteria, the Legal Guardian reject to sign on informed consent. Or at the discretion of study investigator/coinvestigator that the subjects is not appropriate to be included in the study.
研究组 & 干预措施
ulinastatin group
the ulinastatin group will be administered as follows:Ulinastatin 30,000 unit/kg will be diluted into saline solution and administered intravenously in the surgery; Postoperative administration will be 30,000unit/kg divided into 3 regimens until leave ICU.
干预措施: Ulinastatin (Drug)
结局指标
主要结局
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
时间窗: Participants will be followed for the duration of ICU, an expected average of 5 days
Dynamic changes of PaO2/FiO2 ratio will be observed in every 4 hours interval during post-operative ICU stay period
次要结局
- The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery(Participants will be followed for the duration of ICU, an expected average of 5 days)
- The time of the PaO2/ FiO2 Ratio ≥300 post surgery(Participants will be followed for the duration of ICU, an expected average of 5 days)
- Monitoring arterial hydrogen ion concentration(Participants will be followed for the duration of ICU, an expected average of 5 days)
- Monitoring record of mean blood pressure(Intraoperative and Postoperative,an expected average of 6 days)
- Monitoring record of central venous pressure(Intraoperative and Postoperative,an expected average of 6 days)
- Analysis proinflammatory cytokines Interleukin 1(Preoperative and Postoperative on day1 ,day3 and day5)