Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

Cardiac Surgery Clinical Trial

Official title:

High-dose Ulinastatin Improves Postoperative Oxygenation in Patients Undergoing Aortic Valve Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154814
• Other study ID #: KUH1160051
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2017
• Last updated: May 14, 2017
• Start date: January 1, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2017
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

Drug:
• ulinastatin
ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
• control
conventional CPB was applied without ulinastatin treatment

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) during CPB	pulmonary oxygenation	before CPB (Day 0), 2hours after CPB(Day 0), within 6hour after admission to intensive care unit(Day 0)