UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045646 |
|---|---|
| Receipt number | R000052109 |
| Scientific Title | Epidemiological and observational study of critically ill patients with COVID-19 infection in Kumamoto Prefecture |
| Date of disclosure of the study information | 2021/10/11 |
| Last modified on | 2023/02/14 11:32:34 |
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Basic information
Public title
Epidemiological and observational study of critically ill patients with COVID-19 infection in Kumamoto Prefecture
Acronym
Critical ill patients with COVID-19 in Kumamoto Cohort study
Scientific Title
Epidemiological and observational study of critically ill patients with COVID-19 infection in Kumamoto Prefecture
Scientific Title:Acronym
Critical ill patients with COVID-19 in Kumamoto Cohort study
Region
| Japan |
Condition
Condition
Cirical ill patients with COVID-19
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To retrospectively analyze the clinical data and treatment of severe cases of COVID-19 infection in Kumamoto Prefecture, and to compare the prognostic factors and their outcomes with those of ARDS caused by non-COVID-19.
(2)To clarify the reasons and prognosis of palliative respiratory management in severe cases in Kumamoto Prefecture due to the upper limit of respiratory management.
Basic objectives2
Others
Basic objectives -Others
(1) Significance of prognostic factors for classical ARDS in COVID-19 ARDS and prognostic difference by 60-day mortality
(2) Prognosis of palliative respiratory management in severe cases in Kumamoto Prefecture.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Prognostic factors of COVID-19
(2) Hospital mortality of palliative respiratory management in severe cases in Kumamoto Prefecture.
Key secondary outcomes
Comparison of 60-day mortality between critical ill patients with non-COVID-19 ARDS and those with non-COVID-19
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
COVID-19 critical ill patients
Key exclusion criteria
After ethics review and approval in each institution, the information disclosure document will be posted on the website of the research participating institution, and research subjects who do not wish to use the information will be given the opportunity to opt out.
Withdrawal of Consent or Refusal to Participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Ichikado |
Organization
Saiseikai Kumamoto Hospital
Division name
Division of Respiratory Medicine
Zip code
8614101
Address
5-3-1 Chikami, Minami-Ku, Kumamoto City
TEL
+81-96-351-8000
kazuichi6443@gem.bbiq.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Ichikado |
Organization
Saiseikai Kumamoto Hospital
Division name
Division of Respiratory Medicine
Zip code
8614101
Address
5-3-1 Chikami, Minami-Ku, Kumamoto City
TEL
+81-96-351-8000
Homepage URL
kazuichi6443@gem.bbiq.jp
Sponsor or person
Institute
Division of Respiratory Medicine
Saiseikai Kumamoto Hospital
5-3-1 Chikami, Minami-Ku, Kumamoto City
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto University Hospital
Kumamoto City Hospital
Kumamoto Medical Center
Kumamoto Red Cross Hospital
Kumamoto Central Hospital
Kumamoto Regional Medical Center
Kumamoto General Hospital
Hitoyoshi General Medical Center
Kikuchi Medical Association Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Kumamoto Hospital
Address
5-3-1 Chikami, Minami-Ku, Kumamoto City
Tel
0963518000
natsuko-imura@saiseikaikumamoto.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
済生会熊本病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 11 | 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
98
Results
Results
According to multivariate regression analyses, the McCabe score for prognosis of underlying disease (HR 2.74, 95%CI 1.57-4.80, p < 0.001) and the disseminated intravascular coagulation score (HR 1.49, 95%CI 1.13-1.98, p = 0.004) were independent prognostic factors for COVID-19 ARDS.
Conclusion
The extent of DIC and the prognosis of the comorbidity should be considered for use in personalized medicine for patients with ARDS due to COVID-19.
Results date posted
| 2023 | Year | 02 | Month | 14 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because I am writing paper
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 24 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Age, Geder, Hight, Weight, Body mass index (BMI)
Comorbidities (diabetes, hypertension, chronic kidney disease, chronic renal failure, chronic hepatitis, liver cirrhosis, malignant diseases (solid cancer, hematological diseases, others), COPD/emphysema, interstitial pneumonia, others)
Information at the time of ventilatory start: number of days since onset, PaO2/FIO2, severity of illness if Berlin definition is met (mild. moderate, severe), severity of general condition (APACHE II score), degree of multi-organ failure (SOFA score), prognosis of underlying disease (McCabe score( non-fatal, near fatal, fatal)
Complications during treatment (thromboembolism, aspiration pneumonia, etc.)
Management information
Registered date
| 2021 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052109
