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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
