UMIN-CTR Clinical Trial

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
Email	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
Email	mind_koma@yahoo.co.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051636