UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045201 |
|---|---|
| Receipt number | R000051636 |
| Scientific Title | Consideration of the relationship between COVID-19 severe respiratory failure and pancreatic injury |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2021/08/19 16:35:26 |
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Basic information
Public title
Consideration of the relationship between COVID-19 severe respiratory failure and pancreatic injury
Acronym
Pancreatic injury in patients with COVID-19
Scientific Title
Consideration of the relationship between COVID-19 severe respiratory failure and pancreatic injury
Scientific Title:Acronym
Pancreatic injury in patients with COVID-19
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current Coronavirus Disease 2019 (COVID-19) pandemic has had a profound impact on the world. Coronavirus-2 severe respiratory failure syndrome (SARS-CoV-2) is a viral infection that causes organ damage, mainly in the lungs. On the other hand, there are scattered reports of an association between COVID-19 and the development of thrombosis. One of these organs is the pancreas.
Basic objectives2
Others
Basic objectives -Others
Although the supine position is becoming the standard of care for SARS-CoV-2, acute pancreatitis has been reported as a rare complication of the supine position. While there have been reports of hyperamylasemia (AMY) due to the supine position, there have also been reports of acute pancreatitis suspected to be related to COVID-19 in the pancreas. In this study, we retrospectively reviewed the cases of ICU management for severe respiratory failure, and examined the cases with hyper-AMYemia. We also review the data of patients whose number is expected to increase in the future as a prospective observational study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood amylase, pancreatic amylase, and lipase due to body position and administered drugs, and associated diagnostic imaging
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
COVID-19 patients with severe respiratory failure admitted to the ICU between March 1, 2020 and December 31, 2025.
Key exclusion criteria
Patients who are judged as inappropriate subjects by the researcher, etc., or subjects who voluntarily request exclusion.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nishida |
Organization
Fujita Health University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2270
nishida@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Komatsu |
Organization
Fujita Health University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2270
Homepage URL
mind_koma@yahoo.co.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Fujita Health University School of Medicine
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2000
mind_koma@yahoo.co.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
| 2021 | Year | 08 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 08 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051636
