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NCT01588886 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

Official title:
Institute of Emergency and Critical Care Medicine , School of Yang-Ming University

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01588886
Other study ID # 101013-E
Secondary ID
Status Completed
Phase N/A
First received April 27, 2012
Last updated February 15, 2017
Start date March 2012
Est. completion date August 2015

Study information
Verified date November 2013
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 9000
Est. completion date August 2015
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Chronic kidney disease

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Chronic kidney disease ICD-9 2012-Dec
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