Chronic Kidney DiseaseNCT01588886
Proton Pump Inhibitor Use is Associated With High Risk of Pneumonia in Chronic Kidney Disease Patients
An observational study of Chronic Kidney Disease and Pneumonia, run by Far Eastern Memorial Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease, Pneumonia
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Chronic kidney disease
Who cannot join
- excluded those patients who had ever been diagnosed with CKD before 1997
About this study
Official title: 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.
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.
- Conditions
- Chronic Kidney Disease, Pneumonia
- Keywords
- Proton pump inhibitors, Pneumonia, Retrospective cohort study
- Medical subject headings
- Renal Insufficiency, Chronic, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Chronic kidney disease ICD-9
Measured: 2012-Dec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Chih-Hung, MD, Study director, west-garden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588886
- Sponsor's protocol ID
- 101013-E
- Status last verified
- Nov 2013
- First submitted
- 27 Apr 2012
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 21365243Wu 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 21273036Madanick 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institute of Emergency and Critical Care Medicine , School of Yang-Ming University
- ClinicalTrials.gov ID
- NCT01588886
- Acronym / sponsor ID
- 101013-E
- Conditions
- Chronic Kidney Disease, Pneumonia
- Keywords
- Proton pump inhibitors, Pneumonia, Retrospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Chronic kidney disease
Key exclusion criteria (1 listed)
- excluded those patients who had ever been diagnosed with CKD before 1997
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic kidney disease ICD-9
Time frame: 2012-Dec
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Results publication: PubMed 21365243Sheen 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.
- Results publication: PubMed 21273036Wu 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.
- Results publication: PubMed 21199906Madanick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Chih-Hung, MD study director
west-garden Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Pneumonia, run by Far Eastern Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic kidney disease ICD-9 (time frame: 2012-Dec). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588886, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.