UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041433 |
|---|---|
| Receipt number | R000047300 |
| Scientific Title | investigate the effects of evidence-based ICU care on long-term outcomes of Sepsis or Septic Shock: the ILOSS Registry |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2023/08/20 09:02:44 |
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Basic information
Public title
investigate the effects of evidence-based ICU care on long-term outcomes of
Sepsis or Septic Shock: the ILOSS Registry
Acronym
ILOSS Study
Scientific Title
investigate the effects of evidence-based ICU care on long-term outcomes of
Sepsis or Septic Shock: the ILOSS Registry
Scientific Title:Acronym
ILOSS Study
Region
| Japan |
Condition
Condition
Sepsis / Septic shock
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of the timing and intensity of early mobilization on the long-term outcomes of the patients with sepsis or septic shock
Basic objectives2
Others
Basic objectives -Others
To investigate the effect of implementation of the ABCDEF bundle on the long-term outcomes of the patients with sepsis or septic shock
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes include survival, which is the most important outcome of this study, and the incidence of PICS defined as any of the following criteria: the presence of (1) physical impairments, (2) cognitive impairments, or (3) mental health disorders at 12-month follow-up
Key secondary outcomes
The secondary outcomes are the scores of the assessments, such as EQ-5D-5L, EQ-VAS, BI, SMQ, HADS subset for anxiety or depression, and IES-R, the job-employment status, weight loss or recovery after hospital discharge, rehospitalization or readmission to ICU, and the necessity to visit the department of emergency medicine, rehabilitation, or psychiatric. The data on the incidence of PICS-F defined as mental health disorders of the family after the patients hospital discharge will be also collected
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First ICU admission with the diagnosis of sepsis or septic shock
between 1st November 2020 and 30th April 2022
Key exclusion criteria
under 18 years
the patients who had admitted to the ICU within one year under the same diagnosis of sepsis or septic shock
the patients with COVID-19
the patients who are expected to discharge the ICU within 48 hours
the patients whose diagnosis at the time of ICU admission was not sepsis or septic shock
the patients with neurological dysfunction
the patients who have difficulties to communicate with the medical staffs
the patients who could not ambulate independently before the ICU admission
end of care / terminal care
Target sample size
362
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ogura |
Organization
Saiseikai Utsunomiya Hospital
Division name
Department of Emergency Medicine and Critical Care Medicine
Zip code
321-0974
Address
911-1, Takebayashi-machi, Utsunomiya
TEL
0286265500
alongthelongestway2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
The Prince Charles Hospital
Division name
Critical Care Research Group
Zip code
4032
Address
627 Rode Rd, Chermside QLD
TEL
0286265500
Homepage URL
keiliu0406@gmail.com
Sponsor or person
Institute
Saiseikai Utsunomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Utsunomiya Hospital
Address
911-1 Takebayashi-machi, Utsunomiya-shi
Tel
0286265500
keiliu0406@gmail.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.jaam.jp/info/2020/info-iloss_study.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
350
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Japan Society for Emergency Medicine (JSME) led a multi-design study
Study starts on 1 November.
The number of registrations has been slow due to the strong impact of COVID-19, but the study period has been extended.
The patient enrolment period has been extended to 30 April 2022.
Management information
Registered date
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047300
