Congenital Heart Diseases
Conditions
Keywords
ulinastatin, CPB, pediatric
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.
Interventions
DRUGUlinastatin
Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative
Sponsors
Shanghai Children's Medical Center
Guangzhou Women and Children's Medical Center
Guangzhou General Hospital of Guangzhou Military Command
Nanjing Children's Hospital
Children's Hospital of Fudan University
Techpool Bio-Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Days to 4 Years
Healthy volunteers
No
Inclusion criteria
1. Children diagnosed with Complex Congenital Heart Disease . 2. Hospitalized children, both gender, aged ≥ 30 days to ≤ 4 years. 3. Preoperative assessment meet with surgical condition. 4. Without signs of Liver, Kidney, and Coagulatory dysfunction. 5. Written informed consent form has been signed by the Legal Guardian.
Exclusion criteria
1. Patients will accept minimally invasive surgery or palliative surgery, as well as Major Aortopulmonary Collateral Arteries (MAPCAs); 2. Its decided that subject needs to undergo second surgery in a short period of time, or underwent other major surgery. 3. Subjects with known hypersensitivity to study medication (Ulinastatin for Injection) or patients with highly allergic history. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| Monitoring record of mean blood pressure | Intraoperative and Postoperative,an expected average of 6 days |
Countries
China
Outcome results
None listed