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

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. Read our disclaimer for details. Identifier: NCT01588886
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

Brief Summary:
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 or disease
Chronic Kidney Disease Pneumonia

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.

Study Type : Observational
Actual Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Institute of Emergency and Critical Care Medicine , School of Yang-Ming University
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Chronic kidney disease ICD-9 [ Time Frame: 2012-Dec ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • Chronic kidney disease

Exclusion Criteria:

  • excluded those patients who had ever been diagnosed with CKD before 1997

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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 identifier (NCT number): NCT01588886

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

Publications of Results:
Responsible Party: Far Eastern Memorial Hospital Identifier: NCT01588886     History of Changes
Other Study ID Numbers: 101013-E
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: November 2013

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

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