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Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03154814
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
16
Actual Duration (Months)
40
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Retrospective cohort studyRetrospective cohort study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High-dose Ulinastatin Improves Postoperative Oxygenation in Patients Undergoing Aortic Valve Surgery With Cardiopulmonary Bypass
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: ulinastatin treatment

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

Drug: ulinastatin
ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
Other Names:
  • ulinastatin administration

    		•
    Placebo Comparator: control

    conventional CPB was applied without ulinastatin treatment

    Drug: control
    conventional CPB was applied without ulinastatin treatment
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konkuk University Medical Center Seoul Korea, Republic of 133-798
    2 Konkuk University Medical Center Seoul Korea, Republic of 143-729

    Sponsors and Collaborators

    • Konkuk University Medical Center

    Investigators

    • Principal Investigator: Tae-yop Kim, Konkuk University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tae-Yop Kim, MD PhD, Professor, Konkuk University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03154814
    Other Study ID Numbers:
    • KUH1160051
    First Posted:
    May 16, 2017
    Last Update Posted:
    May 16, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tae-Yop Kim, MD PhD, Professor, Konkuk University Medical Center
    ulinastatin
    cardiopulmonary bypass
    cardiac surgery
    Additional relevant MeSH terms:
    Urinastatin

    Study Results

    No Results Posted as of May 16, 2017