Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
- Registration Number
- NCT02527811
- Lead Sponsor
- Techpool Bio-Pharma Co., Ltd.
- Brief Summary
1. 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
2. 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ulinastatin group Ulinastatin 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.
- Primary Outcome Measures
Name Time Method Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
General Hospital of Guangzhou Millitary Command
🇨🇳Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China
Shanghai Children's Medical Center
🇨🇳Shanghai, China
Nanjing Children's Hospital
🇨🇳Nanjing, Jiangsu, China
Children's Hospital of Fudan University
🇨🇳Shanghai, China