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

This study is not yet open for participant recruitment.
Verified January 2016 by National Taiwan University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642081
First Posted: December 30, 2015
Last Update Posted: January 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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
Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Change from baseline in serum creatinine at 1 month [ Time Frame: 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:
  • Admission for acute decompensated heart failure [ Time Frame: 1 month after exposure to NSAIDs ]

Estimated Enrollment: 100
Study Start Date: January 2016
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients with prescription of NSAIDs
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642081


Contacts
Contact: Chii-Ming Lee 886-972-651-087 chiiminglee@ntu.edu.tw
Contact: Po-Lin Chen 886-919-552-322 r03451008@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Chii-Ming Lee    886-972-651-087    chiiminglee@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chii-Ming Lee National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02642081     History of Changes
Other Study ID Numbers: 201511075RIND
First Submitted: December 17, 2015
First Posted: December 30, 2015
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by National Taiwan University Hospital:
NSAIDs
Heart failure
Acute kidney injury

Additional relevant MeSH terms:
Heart Failure
Acute Kidney Injury
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents