Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

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

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

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Diseases
• Intervention / Treatment: Drug: Ulinastatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Shanghai Children's Medical Center
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women And Children's Medical Center
    • Guangzhou, Guangdong, China, 510010
      • General Hospital of Guangzhou Millitary Command
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ulinastatin; Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative; Other Names: UTI; urinary trypsin inhibitor; bikunin
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio	Dynamic changes of PaO2/FiO2 ratio will be observed in every 4 hours interval during post-operative ICU stay period	Participants will be followed for the duration of ICU, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Techpool Bio-Pharma Co., Ltd.
• Collaborators: Children's Hospital of Fudan University; Shanghai Children's Medical Center; Guangzhou General Hospital of Guangzhou Military Command; Guangzhou Women and Children's Medical Center; Nanjing Children's Hospital
• Investigators: Study Chair: Wei Wang, MD, Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pediatric; CPB; ulinastatin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Urinastatin; Trypsin Inhibitors
• Other Study ID Numbers: GDTP-CDMA-201402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided