Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Congenital Heart Diseases

Intervention / Treatment
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* Drug: Ulinastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ulinastatin group<br>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. | Drug: Ulinastatin<br>* Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative<br>* Other names: bikunin;|
| No Intervention: control group<br>patients of control group received conventional therapy,eg,General anesthetic drug and monitoring during the whole process of surgery;Mechanical ventilation and close monitoring to prevent and manage respiratory acidosis and alkalosis and so on. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants will be followed for the duration of ICU, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulinastatin, CPB, pediatric