Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

May 14, 2017 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 133-798
        • Konkuk University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ulinastatin treatment
ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
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
conventional CPB was applied without ulinastatin treatment
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before CPB (Day 0), 2hours after CPB(Day 0), within 6hour after admission to intensive care unit(Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 14, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 14, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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