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Completed

NCT Number: NCT03154814

Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

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

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ulinastatin

Drug

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

Other names: ulinastatin administration

Control

Drug

conventional CPB was applied without ulinastatin treatment

Other names: placebo

Primary outcomes

  1. change of arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) during CPB

    Time frame: before CPB (Day 0), 2hours after CPB(Day 0), within 6hour after admission to intensive care unit(Day 0)

    pulmonary oxygenation

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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