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Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Primary Purpose

Congenital Heart Diseases

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ulinastatin
Sponsored by
Techpool Bio-Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Diseases focused on measuring ulinastatin, CPB, pediatric

Eligibility Criteria

30 Days - 4 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • General Hospital of Guangzhou Millitary Command
  • Guangzhou Women and Children's Medical Center
  • Nanjing Children's Hospital
  • Shanghai Children's Medical Center
  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ulinastatin group

control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The time of the PaO2/ FiO2 Ratio ≥300 post surgery
The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery
Monitoring arterial hydrogen ion concentration
Monitoring record of mean blood pressure
Monitoring record of central venous pressure
Analysis proinflammatory cytokines Interleukin 1

Full Information

First Posted
December 18, 2014
Last Updated
January 16, 2018
Sponsor
Techpool Bio-Pharma Co., Ltd.
Collaborators
Shanghai Children's Medical Center, Guangzhou Women and Children's Medical Center, Guangzhou General Hospital of Guangzhou Military Command, Nanjing Children's Hospital, Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02527811
Brief Title
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Techpool Bio-Pharma Co., Ltd.
Collaborators
Shanghai Children's Medical Center, Guangzhou Women and Children's Medical Center, Guangzhou General Hospital of Guangzhou Military Command, Nanjing Children's Hospital, Children's Hospital of Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Diseases
Keywords
ulinastatin, CPB, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ulinastatin group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ulinastatin
Other Intervention Name(s)
UTI, urinary trypsin inhibitor, bikunin
Intervention Description
Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative
Primary Outcome Measure Information:
Title
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
Description
Dynamic changes of PaO2/FiO2 ratio will be observed in every 4 hours interval during post-operative ICU stay period
Time Frame
Participants will be followed for the duration of ICU, an expected average of 5 days
Secondary Outcome Measure Information:
Title
The time of the PaO2/ FiO2 Ratio ≥300 post surgery
Time Frame
Participants will be followed for the duration of ICU, an expected average of 5 days
Title
The proportion of the PaO2/ FiO2 Ratio ≥300 post surgery
Time Frame
Participants will be followed for the duration of ICU, an expected average of 5 days
Title
Monitoring arterial hydrogen ion concentration
Time Frame
Participants will be followed for the duration of ICU, an expected average of 5 days
Title
Monitoring record of mean blood pressure
Time Frame
Intraoperative and Postoperative,an expected average of 6 days
Title
Monitoring record of central venous pressure
Time Frame
Intraoperative and Postoperative,an expected average of 6 days
Title
Analysis proinflammatory cytokines Interleukin 1
Time Frame
Preoperative and Postoperative on day1 ,day3 and day5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Wang, MD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Guangzhou Millitary Command
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Children's Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

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