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Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nafamostat mesilate
Normal saline
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who were admitted to the intensive care unit and required CRRT

    1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
    2. activated partial thromboplastin time > 60 s,
    3. prothrombin time-international normalized ratio > 2.0,
    4. thrombocytopenia (<100,000/µL), and
    5. surgery within 48 h before CRRT.

Exclusion Criteria:

  • Pregnant or possibly pregnant women
  • Patients who were allergic to nafamostat mesilate
  • Patients who were hypercoagulable

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Nafamostat mesilate group

    No anticoagulation group

    Arm Description

    Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.

    Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy.

    Outcomes

    Primary Outcome Measures

    Number of filters used per hour

    Secondary Outcome Measures

    Urea reduction ratio
    Survival rate

    Full Information

    First Posted
    June 11, 2015
    Last Updated
    June 22, 2015
    Sponsor
    Kyungpook National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02478242
    Brief Title
    Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kyungpook National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.
    Detailed Description
    Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.

    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
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nafamostat mesilate group
    Arm Type
    Active Comparator
    Arm Description
    Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.
    Arm Title
    No anticoagulation group
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Nafamostat mesilate
    Other Intervention Name(s)
    Futhan
    Intervention Description
    nafamostat mesilate use for anticoagulation
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Primary Outcome Measure Information:
    Title
    Number of filters used per hour
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Urea reduction ratio
    Time Frame
    24 months
    Title
    Survival rate
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who were admitted to the intensive care unit and required CRRT active bleeding such as gastrointestinal bleeding and intracranial hemorrhage, activated partial thromboplastin time > 60 s, prothrombin time-international normalized ratio > 2.0, thrombocytopenia (<100,000/µL), and surgery within 48 h before CRRT. Exclusion Criteria: Pregnant or possibly pregnant women Patients who were allergic to nafamostat mesilate Patients who were hypercoagulable
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chan-Duck Kim, M.D., PhD
    Organizational Affiliation
    Associate Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33314078
    Citation
    Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
    Results Reference
    derived

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