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CompletedNCT01588886Updated Feb 16, 2017

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

An observational study in Chronic Kidney Disease and Pneumonia, sponsored by Far Eastern Memorial Hospital. Completed. Per ClinicalTrials.gov, last updated 2017-02-16.

Sponsored by Far Eastern Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
9,000
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Kidney Disease
  • Pneumonia

Keywords

  • Proton pump inhibitors
  • Pneumonia
  • Retrospective cohort study
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 9,000 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
9,000 participants (actual)

Groups and 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.

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What researchers measure

Primary outcomes

  1. Chronic kidney disease ICD-9

    Time frame: 2012-Dec

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Sheen E, Triadafilopoulos G. Adverse effects of long-term proton pump inhibitor therapy. Dig Dis Sci. 2011 Apr;56(4):931-50. doi: 10.1007/s10620-010-1560-3. Epub 2011 Mar 2. PubMed 21365243 ↗
  • Wu H, Jing Q, Wang J, Guo X. Pantoprazole for the prevention of gastrointestinal bleeding in high-risk patients with acute coronary syndromes. J Crit Care. 2011 Aug;26(4):434.e1-6. doi: 10.1016/j.jcrc.2010.12.007. Epub 2011 Jan 26. PubMed 21273036 ↗
  • Madanick RD. Proton pump inhibitor side effects and drug interactions: much ado about nothing? Cleve Clin J Med. 2011 Jan;78(1):39-49. doi: 10.3949/ccjm.77a.10087. PubMed 21199906 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01588886
Lead sponsor
Far Eastern Memorial Hospital
Responsible party
Sponsor
First posted
May 1, 2012
Start date
Mar 2012
Primary completion
Jun 2012
Completion
Aug 2015
Last update
Feb 16, 2017

Study contacts

Chen Chih-Hung, MD
study director · west-garden Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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