UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological investugation of ventilator associated pneumonia in Japanesee critical care center:multicenter observational study
Title of the study (Brief title)	Epidemiological investugation of ventilator-associated pneumonia
Region	Japan

Condition
Condition	Ventilator associated pneumonia
Classification by specialty	Pneumology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the incidence and risk factors of ventilator asscociated pneumonia in Japanese critical care center and the adequacy of the antimicrobial treatment.
Basic objectives2	Others
Basic objectives -Others	To validate 2005 ATS/IDSA guidelines and clinical practice guidelines for nosocomial pneumonia of Japanese respiratory society.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of VAP
Key secondary outcomes	Duration of mechanical ventilation, Length of ICU stay, Length of hospital stay, Hospital mortality rate,

Base
Study type	Observational

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	Mechanical ventilatio for more than 48 hours in Japanese critical care center or ICU
Key exclusion criteria	DNR order Data deficiencies
Target sample size	500

Research contact person
Name of lead principal investigator	Nobuyuki Saito
Organization	Shock and Trauma center, Chiba Hokusoh Hospital, Nippon Medical School
Division name	Department of emergency and critical care medicine
Address	Kamakari 1715, inzai, chiba pref, Japan
TEL	0476-99-1111
Email	nobu99@nms.ac.jp

Public contact
Name of contact person	Nobuyuki Saito
Organization	Shock and Trauma center, Chiba Hokusoh Hospital, Nippon Medical School
Division name	Department of emergency and critical care medicine
Address	Kamakari 1715, inzai, chiba pref, Japan
TEL	0476-99-1111
Homepage URL
Email	nobu99@nms.ac.jp

Sponsor
Institute	Department of emergency and critical care medicine, Shock and Trauma center, Chiba Hokusoh Hospital, Nippon Medical School
Institute
Department

Funding Source
Organization	Department of emergency and critical care medicine, Shock and Trauma center, Chiba Hokusoh Hospital, Nippon Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 02 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 20 Day
Anticipated trial start date	2011 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2013 Year 08 Month 04 Day
Date analysis concluded	2014 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	This study is aimed to validate 2005 ATS/IDSA guidelines and clinical practice guidelines for nosocomial pneumonia of Japanese respiratory society.

Management information
Registered date	2014 Year 02 Month 11 Day
Last modified on	2016 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015314