Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass
High-dose Ulinastatin Improves Postoperative Oxygenation in Patients Undergoing Aortic Valve Surgery With Cardiopulmonary Bypass
1 other identifier
interventional
80
1 country
2
Brief Summary
Retrospective study determine whether ulinastatin enhances postoperative pulmonary oxygenation after cardiopulmonary bypass (CPB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedMay 16, 2017
May 1, 2017
1.2 years
May 11, 2017
May 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
ulinastatin treatment
EXPERIMENTALulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
control
PLACEBO COMPARATORconventional CPB was applied without ulinastatin treatment
Interventions
ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
Eligibility Criteria
You may qualify if:
- patients who underwent aortic repair or replacement under moderate hypothermic CPB
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Konkuk University Medical Center
Seoul, 133-798, South Korea
Konkuk University Medical Center
Seoul, 143-729, South Korea
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Tae-yop Kim
Konkuk University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 16, 2017
Study Start
January 1, 2016
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
May 16, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share