Proton Pump Inhibitor Use is Associated With High Risk of Pneumonia in Chronic Kidney Disease Patients

This study has suspended participant recruitment.
(review)
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01588886
First received: April 27, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

Chronic kidney disease is a severe medical problem in Taiwan public health issue, which the highest incidence and prevalence rate in the world.Proton pump inhibitors may increase the risk of pneumonia appearance, which were caused by profound irreversible gastric acid suppression. The study purpose was to characterize difference of developing pneumonia in chronic kidney disease of prior use proton pump inhibitors.


Condition
Chronic Kidney Disease
Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Institute of Emergency and Critical Care Medicine , School of Yang-Ming University

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Chronic kidney disease ICD-9 [ Time Frame: 2012-Dec ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9000
Study Start Date: March 2012
Estimated Study Completion Date: November 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
with PPI
CKD with PPI use, follow up at least 5 years began PPI use
with or without Pneumonia outcome
Patients were eligible for inclusion if they received any PPIs treatment between January 1, 1998 and December 31, 2002 and had been diagnosed with pneumonia between January 1, 1998 and December 31, 2008 in an inpatient setting.

Detailed Description:

The study used data from Taiwan Health Insurance Research Database; the investigators conducted a population-based cohort study in Taiwan. Case consisted of all patients who had a first diagnosis of chronic kidney disease for the period between 1997 and 2008. The investigators utilized the use of Proton pump inhibitor from chronic kidney disease patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Investiators use the longitudinal health insurance database 2008 (LHID 2008) released by the Taiwan National Health Research Institutes (NHRI) in 2009. Taiwan implemented its National Health Insurance (NHI) program in 1995 to provide affordable health care for all the island's residents.

Criteria

Inclusion Criteria:

  • Chronic kidney disease

Exclusion Criteria:

  • excluded those patients who had ever been diagnosed with CKD before 1997
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01588886

Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Director: Chen Chih-Hung, MD west-garden Hospital
  More Information

Publications:
Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01588886     History of Changes
Other Study ID Numbers: 101013-E
Study First Received: April 27, 2012
Last Updated: November 6, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
Proton pump inhibitors
Pneumonia
Retrospective cohort study

Additional relevant MeSH terms:
Kidney Diseases
Pneumonia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Renal Insufficiency
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014