Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Congenital Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Ulinastatin

Intervention Type DRUG

Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ulinastatin

Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative

Intervention Type DRUG

Other Intervention Names

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UTI urinary trypsin inhibitor bikunin

Eligibility Criteria

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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.

Minimum Eligible Age

30 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No