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The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ulinastatin
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Kidney Injury

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • From January 2015 to June 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou University Hospital.

Exclusion Criteria:

  • Patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Sham Comparator

    Arm Label

    Control

    Ulistin

    Arm Description

    Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.

    In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia. Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.

    Outcomes

    Primary Outcome Measures

    The incidence of acute kidney injury
    Cr ≥ 0.3 mg/dl within 48 hours after surgery, 1.5 times higher preoperative value within 7 days, urine volume <0.5 ml/kg for 6 hours after surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2020
    Last Updated
    July 15, 2020
    Sponsor
    Ajou University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04473144
    Brief Title
    The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
    Official Title
    The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been reported as 7-40% depending on the type of surgery, and is known to increase to about 50% when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is still unknown. Therefore prevention of occurrence is very important. Known factors related to the development of CSA-AKI include hemodynamic, inflammatory, metabolic, and nephrotoxic factors, and since there is a close connection between hypotension due to deterioration of cardiac function, preventive measures to prevent hypotension in juicing It is only possible. To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported to protect against renal ischemia/reperfusion injury. Various studies have been attempted to prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed only for surgery with extracorporeal circulation that causes severely. Therefore, this study would like to verify the effectiveness of ulistine's medicine in the prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without extracorporeal circulation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.
    Arm Title
    Ulistin
    Arm Type
    Sham Comparator
    Arm Description
    In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia. Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Ulinastatin
    Intervention Description
    In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.
    Primary Outcome Measure Information:
    Title
    The incidence of acute kidney injury
    Description
    Cr ≥ 0.3 mg/dl within 48 hours after surgery, 1.5 times higher preoperative value within 7 days, urine volume <0.5 ml/kg for 6 hours after surgery
    Time Frame
    7 days after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: From January 2015 to June 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou University Hospital. Exclusion Criteria: Patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ji young yoo, assistant professor
    Phone
    821056902104
    Email
    springbear@nate.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study

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