UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039424 |
|---|---|
| Receipt number | R000044803 |
| Scientific Title | The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/02/07 |
| Last modified on | 2020/02/07 11:33:28 |
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Basic information
Public title
The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Acronym
The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Scientific Title
The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Scientific Title:Acronym
The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Pneumonia
Classification by specialty
| Medicine in general | Pneumology | Neurology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of ACE inhibitors for prevention of pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of pneumonia(Duration: the longest follow-up of each primary study), Definition: the presence of new pneumonic changes in the chest x-ray and clinical signs of pneumonia; cough, fever, sputum production and pleuritic chest pain. we will also accept pneumonia as the original authors defined)
Key secondary outcomes
Mortality(Duration: the longest follow-up of each primary study)
Withdrawal due to adverse effects(Duration: the longest follow-up of each primary study)
Swallowing function(Duration: the longest follow-up of each primary study, Definition:Assessed by the Royal Brisbane Hospital Outcome Measure for Swallowing(RBHOMS) score, the dysphagia severity rating scale (DSRS), the functional oral intake scale (FOIS), the dysphagia outcome and severity scale (DOSS), or water swallowing tests)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nothing
Key exclusion criteria
Nothing
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Tsunoda |
Organization
Shiga University of Medical Science Hospital
Division name
Department of family medicine
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2929
hidekit0731@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Tsunoda |
Organization
Shiga University of Medical Science Hospital
Division name
Department of family medicine
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2929
Homepage URL
hidekit0731@gmail.com
Sponsor or person
Institute
Shiga University of Medical Science Hospital, Department of family medicine
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science Hospital, Department of family medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Hospital
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
Tel
077-548-2929
hidekit0731@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Types of studies>
We will include all randomized controlled trials(RCTs), quasi-RCTs and observational studies.
<Search Methods for identification of studies>
We will search the following databases for the relevant studies.
the Cochrane Central Register of Controlled Trials(CENTRAL);
MEDLINE via Ovid;
EMBASE;
We will also use the resources below.
the World Health Organization International Clinical Trials Platform Search Portal(ICTRP)
ClinicalTrials.gov
We will also search reference lists of included studies and clinical practice guidelines(ACC/ AHA/ ESC/ ESH).
<Assessment of risk of bias in included studies>
RCTs will be assessed by two authors independently using Risk of Bias 2 tool.
Quasi-RCT/ non-RCT/ Observational studies will be assessed using Newcasstle-Ottawa scale
<Subgroup analysis and investigation of heterogeneity>
We will perform subgroup analysis for the primary outcome (incidence of pneumonia) as follows.
1. Race: Asian or not
2. Patients with or without a history of stroke.
3. Patients with or without neurodegenerative diseases.
4. Age: Elderly patients(Studies that included a minority(<20%) of patients under 65 years old will be included.) or not.
5. Study follow-up: short (<= 3 months), intermediate (3 months to 24 months), or long term (> 24 months)
<Sensitivity analysis>
We will perform sensitivity analysis for the primary outcome as follows.
1. Exclusion of studies using imputed statistics.
2. Exclusion of studies using the diagnostic criteria of pneumonia other than the presence of new pneumonic changes in the chest x-ray and clinical signs of pneumonia; cough, fever, sputum production and pleuritic chest pain.
3. Using the effect estimates from univariable analyses instead of those from multivariable analyses
<"Summary of findings" tables>
We will present following results of the review in "Summary of findings" tables.
1. The incidence rate of pneumonia
2. Mortality
3. Withdrawal due to adverse effects
4. Swallowing function
Management information
Registered date
| 2020 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044803
