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

Techpool Bio-Pharma Co., Ltd.5 sites in 1 country450 target enrollmentApril 2015

ConditionsCongenital Heart Diseases

InterventionsUlinastatin

DrugsUlinastatin

Overview

Phase: Phase 4
Intervention: Ulinastatin
Conditions: Congenital Heart Diseases
Sponsor: Techpool Bio-Pharma Co., Ltd.
Enrollment: 450
Locations: 5
Primary Endpoint: Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

December 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Techpool Bio-Pharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

ulinastatin group

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.

Intervention: Ulinastatin

Outcomes

Primary Outcomes

Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio

Time Frame: 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 Outcomes

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)