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Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02642081
Collaborator
(none)
100
Enrollment
1
Location
5
Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to NSAIDs within 30 days.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure
    Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Jun 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in serum creatinine at 1 month [Baseline and 1 month]

      We collect not only patient's baseline serum creatinine level (defined as the median value of the previous-six-months serum creatinine), but also serum creatinine level on the detecting day (defined as the most recent day from index date we detecting the serum creatinine). Acute kidney injury is defined as the absolute increase in the serum creatinine concentration of ≥0.3 mg/dL from baseline; or a percentage increase in the serum creatinine concentration of ≥50 percent.

    Secondary Outcome Measures

    1. Admission for acute decompensated heart failure [1 month after exposure to NSAIDs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    1. Patient's age was more than 20 years old

    2. Diagnosis of heart failure

    3. With prescription of NSAIDs (only oral and intravenous form are included)

    Exclusion criteria

    1. With prescription of NSAIDs administered by topical use

    2. Patient was pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Chii-Ming Lee, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02642081
    Other Study ID Numbers:
    • 201511075RIND
    First Posted:
    Dec 30, 2015
    Last Update Posted:
    Jan 7, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by National Taiwan University Hospital
    NSAIDs
    Heart failure
    Acute kidney injury
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Heart Failure

    Study Results

    No Results Posted as of Jan 7, 2016