Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03154814

Enrollment

Registered

2017-05-16

Start date

2016-01-01

Completion date

2017-05-01

Last updated

2017-05-16

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

Conditions

Cardiac Surgery, Cardiopulmonary Bypass

Keywords

ulinastatin, cardiopulmonary bypass, cardiac surgery

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.

Interventions

DRUGulinastatin

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

DRUGcontrol

conventional CPB was applied without ulinastatin treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Retrospective cohort study

Eligibility

Sex/Gender

ALL

Age

19 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026