Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Techpool Bio-Pharma

Status and phase: Unknown; Phase 4

Conditions: Congenital Heart Diseases

Treatments: Drug: Ulinastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02527811

GDTP-CDMA-201402

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 30 days to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

ulinastatin group

Experimental group

Description:

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.

Treatment:

Drug: Ulinastatin

control group

No Intervention group

Description:

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.