A controlled, randomized clinical study in organ function protection and safety of UTI in patients, who has CPB (Cardiopulmonary bypass) with complex congenital heart disease

Trial for UTI in the treatment of children with complex congenital heart disease receiving CPB

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14005219

Enrollment

Unknown

Registered

2014-09-03

Start date

2014-09-30

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease

Interventions

Study Group:intravenous injecting ulinastatin for injection

Control:intravenous injecting ulinastatin for injection

Eligibility

Sex/Gender

All

Age

1 Years to 4 Years

Inclusion criteria

Inclusion criteria: 1) Patients with complex congenital heart disease (tetralogy of Fallo (TOF), double outlet of right ventricle (DORV), total abnormal pulmonary venous (TAPVC); Ventricular septal defect with coarctation of the aorta (VSD, CoA), atrioventricular septal defect (CAVC) only), has CPB (Cardiopulmonary bypass) first time; 2) Age: less than 30days, less than 4 years old patients in hospital, both sexes; 3) Match the operation requirements; 4) No function disturbance in liver, kidney and coagulation system; 5) Sign the informed consent by legal guardian.

Exclusion criteria

Exclusion criteria: 1) the patients with minimally invasive surgery or palliative operation, or main collateral branch congenital heart disease; 2) the patients who are not the first-time operation or has other major operation; 3) the patients who has been allergy with UTI or high allergic people; 4) the patients who has match the requirements, however, no legal guardian sign on the informed consent or been denied by the doctor.

Design outcomes

Primary

Measure	Time frame
The dynamic variation of PaO2/FiO;	—

Countries

China

Contacts

Public ContactWang Wei

wangweicpb@yahoo.com+86 18930830665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026