- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588886
Proton Pump Inhibitor Use is Associated With High Risk of Pneumonia in Chronic Kidney Disease Patients
February 15, 2017 updated by: Far Eastern Memorial Hospital
Institute of Emergency and Critical Care Medicine , School of Yang-Ming University
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
9000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Chronic kidney disease
Exclusion Criteria:
- excluded those patients who had ever been diagnosed with CKD before 1997
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Chronic kidney disease ICD-9
Time Frame: 2012-Dec
|
2012-Dec
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chen Chih-Hung, MD, west-garden Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
April 30, 2012
First Posted (Estimate)
May 1, 2012
Study Record Updates
Last Update Posted (Actual)
February 16, 2017
Last Update Submitted That Met QC Criteria
February 15, 2017
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101013-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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