UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054274 |
|---|---|
| Receipt number | R000061980 |
| Scientific Title | Post-Publication Survey of the Japanese Surviving Sepsis Campaign Guidelines for Sustainable Development |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/04/04 21:11:42 |
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Basic information
Public title
Post-Publication Survey of the Japanese Surviving Sepsis Campaign Guidelines for Sustainable Development
Acronym
Post-Publication Survey of the Japanese Surviving Sepsis Campaign Guidelines for Sustainable Development
Scientific Title
Post-Publication Survey of the Japanese Surviving Sepsis Campaign Guidelines for Sustainable Development
Scientific Title:Acronym
Post-Publication Survey of the Japanese Surviving Sepsis Campaign Guidelines for Sustainable Development
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of the Japanese version of the surviving sepsis campaign guidelines (J-SSCG) 2024 on sepsis care in Japan through a post-publication survey.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Survey on the actual status of sepsis care: To assess whether there are differences in the status of care between specialists and non-specialists in the field of emergency intensive care.
2. Survey of compliance with standard treatment at each facility: To clarify the compliance rate of standard treatment regarding sepsis care.
3. Verification of the learning effect of the guidelines: To evaluate changes in the percentage of correct answers to sepsis patient scenario questions created in J-SSCG2024 before and after the guidelines were issued.
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who are able to complete the questionnaire for the Japanese version of surviving sepsis campaign guidelines
Key exclusion criteria
Participants who had difficulty completing the questionnaire for the Japanese version of surviving sepsis campaign guidelines
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Oami |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
TEL
0432227171
seveneleven711thanks39@msn.com
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Oami |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
TEL
0432227171
Homepage URL
seveneleven711thanks39@msn.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Takehiko Oami
Funding Source
Organization
None
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
Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
Tel
0432227171
seveneleven711thanks39@msn.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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background:
Clinical practice guidelines are documents that support decision-making by healthcare professionals and patients based on recommendations. The Japanese version of the surviving sepsis campaign guidelines (J-SSCG) has been revised every four years to improve the quality of sepsis care. To maximize the effectiveness of the guidelines, it is essential to identify clinical questions based on the compliance rate of standard treatment and behavioral change of readers by the guidelines. Therefore, we attempted to construct strategic basic data for the next generation of guideline development by expanding the questionnaire survey conducted after the publication of the guideline and simultaneously clarifying the actual conditions of sepsis care, the compliance rate of standard treatment, and the learning effect of the guideline, in addition to extracting issues in J-SSCG 2024.
Objective:
To clarify the impact of the J-SSCG2024 on sepsis practice in Japan through a post-publication survey.
Methods:
1. To clarify the actual status of sepsis practice in Japan by setting up questions related to the clinical questions in the guidelines in addition to the survey items conducted during J-SSCG 2020. In particular, we will clarify whether there is a difference in the practice situation between specialists and non-specialists in the field of emergency intensive care.
2. To clarify the compliance rate of the standard treatment for sepsis care through the medical safety department at each facility.
3. We will use the sepsis case scenario created in J-SSCG 2024 to identify the learning effect of the guidelines. We will estimate the learning effect of J-SSCG2024 by evaluating changes in the percentage of correct answers to scenario questions before and after publication of J-SSCG2024 among physicians who take the emergency medicine specialist examination, which is the guideline's readership.
Management information
Registered date
| 2024 | Year | 04 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061980
