UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049507 |
|---|---|
| Receipt number | R000056125 |
| Scientific Title | RelatIonship between implementation of evidence-based and suppoRtive ICU care and outcomes of patients with acute respiratory distress syndrome |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/16 12:06:56 |
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Basic information
Public title
RelatIonship between implementation of
evidence-based and suppoRtive ICU care and
outcomes of patients with acute respiratory distress syndrome
Acronym
The ICU LIBERATION study
Scientific Title
RelatIonship between implementation of
evidence-based and suppoRtive ICU care and
outcomes of patients with acute respiratory distress syndrome
Scientific Title:Acronym
The ICU LIBERATION study
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Acute Respiratory Distress Syndrome
Classification by specialty
| Medicine in general | Surgery in general | Operative medicine |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the epidemiology and treatments given to the patients and evaluate the implementation of evidence based ICU care and its association with the outcomes of patients with acute respiratory distress syndrome admitted to the ICU. The contents of mechanical ventilation settings, respiratory conditions, and the evidence -based ICU care, such as analgesia, sedation, rehabilitation, and nutrition, given to the patients will be collected in a daily basis.
Aim 1: Epidemiology
Aim 2: Treatments
Aim 3: Evidence-based ICU care
Basic objectives2
Others
Basic objectives -Others
Aim 1: Epidemiology
Aim 2: Treatments
Aim 3: Evidence-based ICU care
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items will be collected in this study
1) Epidemiology: mortality (survival rate), length of ICU/hospital stay, mechanical ventilation period, etc.
2) Treatment: the achievement of lung-protective ventilation, mechanical ventilation setting, prone positioning, neuromuscular blockade, dialysis, etc.
3) Evidence-based ICU care
3-1) ABCDEF bundle implementation ratio
3-2) Evaluation of PADIS and its compliance status
3-3) Nutrition
3-4) ICU diary
3-5) The presence or absence of physical restraints
3-6) Sleep, etc.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients on an invasive or non-invasive ventilator within 24 hours of ICU admission
2) Patients who are expected to be on an invasive and/or non-invasive ventilator for more than 48 hours in total
3) Patients who meet the diagnosis of ARDS within 24 hours of ICU admission
Key exclusion criteria
1) Patients who are younger than 16 years old
2) Patients with terminal conditions at the time of ICU admission
3) Patients who have been admitted to the ICU with a terminal care policy or who are expected to be admitted to the ICU with a terminal care policy within 24 hours of admission to the ICU
4) Patients who have expressed their refusal to have their clinical data used in research.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
The Japanese Society for Early Mobilization
Division name
LIBERATION Study Steering Committee
Zip code
1020073
Address
2F, Plarel Building, 1-2-12, Kudan-kita 1-chome, Chiyoda-ku, Tokyo 102-0073, Japan
TEL
03-3556-5585
keiliu0406@gmail.com
Public contact
Name of contact person
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
The Japanese Society for Early Mobilization
Division name
LIBERATION Study Steering Committee
Zip code
1020073
Address
2F, Plarel Building, 1-2-12, Kudan-kita 1-chome, Chiyoda-ku, Tokyo 102-0073, Japan
TEL
03-3556-5585
Homepage URL
keiliu0406@gmail.com
Sponsor or person
Institute
The Japanese Society for Early Mobilization
Institute
Department
Personal name
Funding Source
Organization
Japanese association of acute medicine, Drager
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
The Japanese Society for Early Mobilization
Address
2F, Plarel Building, 1-2-12, Kudan-kita 1-chome, Chiyoda-ku, Tokyo 102-0073, Japan
Tel
03-3556-5585
winegood21@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
| 2022 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056125
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
