Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Sponsor

Techpool Bio-Pharma Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02527811

Collaborator

Shanghai Children's Medical Center (Other), Guangzhou Women and Children's Medical Center (Other), Guangzhou General Hospital of Guangzhou Military Command (Other), Nanjing Children's Hospital (Other), Children's Hospital of Fudan University (Other)

450

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Diseases	Drug: Ulinastatin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Days to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Guangzhou Millitary Command	Guangzhou	Guangdong	China	510010
2	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong	China	510623
3	Nanjing Children's Hospital	Nanjing	Jiangsu	China	210000
4	Shanghai Children's Medical Center	Shanghai		China	200127
5	Children's Hospital of Fudan University	Shanghai		China	201102