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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
450
Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative
General Hospital of Guangzhou Millitary Command
Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
Shanghai Children's Medical Center
Shanghai, China
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
Dynamic changes of PaO2/FiO2 ratio will be observed in every 4 hours interval during post-operative ICU stay period
Time frame: 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
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
Monitoring arterial hydrogen ion concentration
Time frame: Participants will be followed for the duration of ICU, an expected average of 5 days
Monitoring record of mean blood pressure
Time frame: Intraoperative and Postoperative,an expected average of 6 days
Monitoring record of central venous pressure
Time frame: Intraoperative and Postoperative,an expected average of 6 days
Analysis proinflammatory cytokines Interleukin 1
Time frame: Preoperative and Postoperative on day1 ,day3 and day5
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Children's Hospital of Fudan University
Shanghai, China