Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Congenital Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02527811
• Other study ID #: GDTP-CDMA-201402
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: December 18, 2014
• Last updated: January 16, 2018
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Techpool Bio-Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Diseases
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Guangzhou Millitary Command	Guangzhou	Guangdong
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	Nanjing Children's Hospital	Nanjing	Jiangsu
China	Children's Hospital of Fudan University	Shanghai
China	Shanghai Children's Medical Center	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Techpool Bio-Pharma Co., Ltd.	Children's Hospital of Fudan University, Guangzhou General Hospital of Guangzhou Military Command, Guangzhou Women and Children's Medical Center, Nanjing Children's Hospital, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Monitoring arterial hydrogen ion concentration		Participants will be followed for the duration of ICU, an expected average of 5 days
Secondary	Monitoring record of mean blood pressure		Intraoperative and Postoperative,an expected average of 6 days
Secondary	Monitoring record of central venous pressure		Intraoperative and Postoperative,an expected average of 6 days
Secondary	Analysis proinflammatory cytokines Interleukin 1		Preoperative and Postoperative on day1 ,day3 and day5