Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

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

Detailed Description
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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.

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

Conditions
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Cardiopulmonary Bypass, Cardiac Surgery

Intervention / Treatment
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* Drug: ulinastatin
* Drug: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Retrospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ulinastatin treatment<br>ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB | Drug: ulinastatin<br>* ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB<br>* Other names: ulinastatin administration;|
| Placebo Comparator: control<br>conventional CPB was applied without ulinastatin treatment | Drug: control<br>* conventional CPB was applied without ulinastatin treatment<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulinastatin, cardiopulmonary bypass, cardiac surgery