Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

Phase 4

Completed

• Conditions: Cardiac Surgery; Cardiopulmonary Bypass
• Interventions: Drug: control; Drug: ulinastatin

• Registration Number: NCT03154814
• Lead Sponsor: Konkuk University Medical Center

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-04-01
• Status Verified: 2017-05
• Study Completion: 2017-05-01
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-14
• Last Update Submitted: 2017-05-14
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	conventional CPB was applied without ulinastatin treatment
ulinastatin treatment	ulinastatin	ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB

Primary Outcome Measures

Name	Time	Method
change of arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) during CPB	before CPB (Day 0), 2hours after CPB(Day 0), within 6hour after admission to intensive care unit(Day 0)	pulmonary oxygenation

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of