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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name