UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Retrospective study of Sepsis treatment in municipal hospital of northern Hokkaido
Title of the study (Brief title)	A Retrospective study of Sepsis treatment in municipal hospital of northern Hokkaido
Region	Japan

Condition
Condition	Sepsis, Septic shock, Septic DIC
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate the efficiency of sepsis treatment, performing retrospective study on effects and cares, including Disseminated Intravascular Coagulation (DIC) and shock caused by sepsis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	90 days mortality of hospital admission
Key secondary outcomes	2 or more SIRS criteria, qSOFA score of 2 or more points, SOFA scores, APACHE II scores, DIC incidence, septic shock incidence, delirium incidence

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients diagnosed of sepsis April of 2015 through March of 2017 diagnosis of sepsis defined by Sepsis-3
Key exclusion criteria	not applicable
Target sample size	64

Research contact person
Name of lead principal investigator	Kumakura Jun
Organization	Nayoro City General Hospital
Division name	Department of Emergency
Address	Nishi 7 jo Minami 8 cho-me 1, Nayoro city, Hokkaido
TEL	01654-3-3101
Email	a100018@al.asahikawa-med.ac.jp

Public contact
Name of contact person	Kumakura Jun
Organization	Nayoro City General Hospital
Division name	Department of Emergency
Address	Nishi 7 jo Minami 8 cho-me 1, Nayoro city, Hokkaido
TEL	01654-3-3101
Homepage URL
Email	a100018@al.asahikawa-med.ac.jp

Sponsor
Institute	Nayoro City General Hospital
Institute
Department

Funding Source
Organization	Nayoro City General Hospital
Organization
Division
Category of Funding Organization	Local Government
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	2018 Year 05 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Septic shock and Septic DIC statistically increased 90 days' mortality (64.0%, 48.3%). Among patients with sepsis admitted to hospital, an increase in SOFA score of 2 or more had greater prognostic accuracy for mortality than SIRS criteria or the qSOFA score. This result was presented at the 45th annual meeting of the Japanese Society of Intensive Care medicine.
Other related information	Monocentric retrospective analysis of 54 patients diagnosed of sepsis demonstrated in the study during April of 2015 through March of 2017.

Management information
Registered date	2018 Year 04 Month 30 Day
Last modified on	2018 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036984