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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039424
Receipt No. 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

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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
Email 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
Email hidekit0731@gmail.com

Sponsor
Institute Shiga University of Medical Science Hospital, Department of family medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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