UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039990
Receipt number 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 23:12:25

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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 or person

Institute

Tsukuba University of hospital

Institute

Department

Personal name



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

Value
https://center6.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