UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052689 |
|---|---|
| Receipt number | R000060119 |
| Scientific Title | Association between strains on intensive care units and clinical outcomes during COVID-19 pandemics in Japan: a multi-center retrospective cohort study |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2025/07/23 21:49:04 |
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Basic information
Public title
Association between strains on intensive care units and clinical outcomes during COVID-19 pandemics in Japan: a multi-center retrospective cohort study
Acronym
Association between strains on intensive care units and clinical outcomes during COVID-19 pandemics in Japan: a multi-center retrospective cohort study
Scientific Title
Association between strains on intensive care units and clinical outcomes during COVID-19 pandemics in Japan: a multi-center retrospective cohort study
Scientific Title:Acronym
Association between strains on intensive care units and clinical outcomes during COVID-19 pandemics in Japan: a multi-center retrospective cohort study
Region
| Japan |
Condition
Condition
Non-COVID-19 adult patients who admitted to intensive care units
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the clinical managememt of non-COVID-19 critically ill patient care during the COVID-19 pandemic and to evaluate in-hospital mortality with that before the COVID-19 pandemic, according to the strain on medical resources.
Basic objectives2
Others
Basic objectives -Others
Medical strain is assessed for each participating hospital based on clinical data from the COVID-19 pandemic at each facility. In addition, for each pandemic wave, the impact of the presence or absence of medical strain on medical care will be examined.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
standardized mortality ratio
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-COVID-19 patients who admitted to ICU
Key exclusion criteria
Re-admitted patient and confirmed or suspected COVID-19
Target sample size
631
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sakuraya |
Organization
JA Hiroshima General Hospital
Division name
Department of Emergency and Intensive Care Medicine
Zip code
738-8503
Address
1-3-3 Jigozen, Hatsukaichi, Hiroshima
TEL
0829-36-3111
masaaki.sakuraya@gmail.com
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Sakuraya |
Organization
JA Hiroshima General Hospital
Division name
Department of Emergency and Intensive Care Medicine
Zip code
738-8503
Address
1-3-3 Jigozen, Hatsukaichi, Hiroshima
TEL
0829-36-3111
Homepage URL
masaaki.sakuraya@gmail.com
Sponsor or person
Institute
JA Hiroshima General Hospital
Institute
Department
Personal name
Masaaki Sakuraya
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
Graduate School of Biomedical and Health Sciences, Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5947
iryo-sinsa@office.hiroshima-u.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
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/ccmjournal/fulltext/9900/association_of_medical_burden_and_capacity_changes
Number of participants that the trial has enrolled
70636
Results
Nine and fourteen ICUs had a limited capacity (25,568 patients) and a maintained capacity (45,068 patients), respectively. SMRs increased in four epidemic waves in the ICUs with a limited capacity but in only one wave in those with a maintained capacity.
Results date posted
| 2025 | Year | 07 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 22 | Day |
Baseline Characteristics
All the ICUs with a limited capacity were located in urban areas, whereas most with a maintained capacity were located in rural areas. The numbers of hospital and ICU beds and the staff-to-ICU-bed ratio were comparable before and during the pandemic in each group. ICU bed occupancy did not change in either group during the pandemic.
Emergency admissions decreased only in ICUs with a maintained capacity. The proportion of patients receiving surgery decreased in ICUs with a limited capacity but increased in those with a maintained capacity. Illness severity scores were higher during the COVID-19 pan- demic compared with those before the pandemic in ICUs with a limited capacity. The mean SOFA score but not the APACHE III score was higher in ICUs with a maintained capacity. The proportion of patients receiving vasoactive drugs increased in ICUs with a limited capacity, but decreased in those with a maintained capacity.
Participant flow
Included patients were categorized into ICUs with a limited capacity and those with a maintained capacity based on the results of a survey conducted at each facility.
Adverse events
None
Outcome measures
SMRs increased in four epidemic waves in the ICUs with a limited capacity but in only one wave in those with a maintained capacity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We divide the facilities into two groups based on the number of severely ill COVID-19 patients and the results of the medical shortage questionnaire, and evaluate the change in standardized mortality ratios before and after the COVID-19 pandemic.
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060119
