Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

NCT ID: NCT03154814

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-05-01

Brief Summary

Retrospective study determine whether ulinastatin enhances postoperative pulmonary oxygenation after cardiopulmonary bypass (CPB).

Detailed Description

This retrospective study evaluate patients who underwent aortic valvular surgery under moderate hypothermic CPB. The patients were classified into two groups: patients in whom high-dose ulinastatin (10,000 U/kg and 5,000 U/kg/h) was administered during CPB (Group-U); and patients in whom ulinastatin was not administered (Group-C). We measured PaO2/FiO2 at the following time points: before CPB (Pre-CPB), 2 hours after weaning from CPB (Post-CPB) and within 6 hours after admission to the ICU. The lengths of ventilator care and ICU stay were also reviewed.

Conditions

Cardiopulmonary Bypass; Cardiac Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ulinastatin treatment

ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB

Group Type: EXPERIMENTAL

ulinastatin

Intervention Type: DRUG

ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB

control

conventional CPB was applied without ulinastatin treatment

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: DRUG

conventional CPB was applied without ulinastatin treatment

Interventions

ulinastatin

ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB

Intervention Type: DRUG

control

conventional CPB was applied without ulinastatin treatment

Intervention Type: DRUG

Other Intervention Names

ulinastatin administration; placebo

Eligibility Criteria

Inclusion Criteria

• patients who underwent aortic repair or replacement under moderate hypothermic CPB

Exclusion Criteria

• Preoperative:

< 19 years old, > 85 years old, emergency operation, reoperation, left ventricular ejection fraction < 50%, arrhythmia, ischaemic myocardial disease, uncontrollable hypertension or hypotension, pericardial disease, pre-existing hepatic dysfunction, pre-existing renal dysfunction or underlying lung disease.

• Intraoperative:

intraoperative application of an intra-aortic balloon pump, administration of steroids or tranexamic acid, and transfusion of fresh frozen plasma or platelet concentrates during CPB.

• Postoperative:

reoperation for surgical correction of intractable postoperative bleeding within 2 hours after the end of surgery and transfusion of any banked blood products.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tae-Yop Kim, MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae-yop Kim

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

Konkuk University Medical Center

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KUH1160051

Identifier Type: -

Identifier Source: org_study_id