Clinical trial NCT02527811: Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Congenital Heart Diseases
Keywords: ulinastatin
CPB
pediatric
Lead sponsor: Techpool Bio-Pharma Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Children's Medical Center
name: Guangzhou Women and Children's Medical Center
name: Guangzhou General Hospital of Guangzhou Military Command
name: Nanjing Children's Hospital
name: Children's Hospital of Fudan University
First posted: 2015-08-19
Enrollment: 450
Sex: ALL
Minimum age (years): 30
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
timeFrame: Participants will be followed for the duration of ICU, an expected average of 5 days
Secondary outcomes:
measure: The time of the PaO2/ FiO2 Ratio ≥300 post surgery
timeFrame: Participants will be followed for the duration of ICU, an expected average of 5 days
measure: The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery
timeFrame: Participants will be followed for the duration of ICU, an expected average of 5 days
measure: Monitoring arterial hydrogen ion concentration
timeFrame: Participants will be followed for the duration of ICU, an expected average of 5 days
measure: Monitoring record of mean blood pressure
timeFrame: Intraoperative and Postoperative,an expected average of 6 days
measure: Monitoring record of central venous pressure
timeFrame: Intraoperative and Postoperative,an expected average of 6 days
measure: Analysis proinflammatory cytokines Interleukin 1
timeFrame: Preoperative and Postoperative on day1 ,day3 and day5
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: General Hospital of Guangzhou Millitary Command
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Shanghai Children's Medical Center
name: Wei Wang, MD
role: STUDY_CHAIR
References: