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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039990
Receipt No. R000045594
Scientific Title Quality improvement projects for time to antibiotics for the patients with sepsis in the emergency department
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/30

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Basic information
Public title Quality improvement projects for the patients with sepsis in the emergency department
Acronym QISEPSISED
Scientific Title Quality improvement projects for time to antibiotics for the patients with sepsis in the emergency department
Scientific Title:Acronym QISEPSISED
Region
Japan

Condition
Condition septic patient's at the Emergency Department (ED)
Classification by specialty
Emergency medicine Intensive care medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the impact of a nurse initiated quality improvement by the primary screening using qSOFA on the sepsis management at the Emergency Department and improvement of patients outcome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome was the antibiotic administration rate after visiting the ED,
Key secondary outcomes Secondary outcome was the 28th day mortality.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria all patients who were visited to ED and were suspected of infection.
Key exclusion criteria patients in whom cardiopulmonary arrest at ED arrival, and already administered antibiotics at ED arrival.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name yohiaki
Middle name
Last name inoue
Organization University of Tsukuba
Division name Emergency and Critical Care Medicine, Faculty of Medicine,
Zip code 305-8576
Address 2-1-1, Amakubo, Tsukuba, Ibaraki
TEL +81-29-853-3900
Email yinoue@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Hatozaki
Organization Tsukuba University of hospital
Division name Intensive Care Unit
Zip code 305-8576
Address 2-1-1, Amakubo, Tsukuba, Ibaraki
TEL +81-29-853-3900
Homepage URL
Email chiehatozaki@gmail.com

Sponsor
Institute Tsukuba University of hospital
Institute
Department

Funding Source
Organization Tsukuba University of hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tsukuba University of hospital
Address 2-1-1, Amakubo, Tsukuba, Ibaraki
Tel +81-29-853-3900
Email t-credo.adm[@]un.tsukuba.ac.jp

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 04 Month 01 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 503
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 Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2019 Year 06 Month 15 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
2019 Year 10 Month 31 Day
Date trial data considered complete
2019 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 03 Month 30 Day
Last modified on
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045594

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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