NCT02527811

Brief Summary

  1. 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

December 18, 2014

Last Update Submit

January 16, 2018

Conditions

Congenital Heart Diseases

Keywords

ulinastatinCPBpediatric

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

ulinastatin group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

UlinastatinDRUG

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

Also known as: UTI, urinary trypsin inhibitor, bikunin
ulinastatin group

Eligibility Criteria

Age30 Days - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

General Hospital of Guangzhou Millitary Command

Guangzhou, Guangdong, 510010, China

Location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location

Nanjing Children's Hospital

Nanjing, Jiangsu, 210000, China

Location

Shanghai Children's Medical Center

Shanghai, 200127, China

Location

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wei Wang, MD

    Shanghai Children's Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

August 19, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

CN(5)