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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000045646
Receipt No. 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 2021/10/03

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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
Email 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
Email kazuichi6443@gem.bbiq.jp

Sponsor
Institute Division of Respiratory Medicine
Saiseikai Kumamoto Hospital
5-3-1 Chikami, Minami-Ku, Kumamoto City
Institute
Department

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
Email 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 date posted
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
2021 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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