UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041768
Receipt number R000047620
Scientific Title A prospective observational study on perioperative serum amylase level changes during cardiac surgery
Date of disclosure of the study information 2020/09/12
Last modified on 2023/07/26 21:15:05

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Basic information

Public title

A prospective observational study on perioperative serum amylase level changes during cardiac surgery

Acronym

A prospective observational study on perioperative serum amylase level changes during cardiac surgery

Scientific Title

A prospective observational study on perioperative serum amylase level changes during cardiac surgery

Scientific Title:Acronym

A prospective observational study on perioperative serum amylase level changes during cardiac surgery

Region

Japan


Condition

Condition

cardiac surgery

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate perioperative serum amylase level and its fractional transition in patients undergoing cardiac surgery.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to determine the effect of renal function on elevated serum amylase levels and the relationship between these enzyme elevations and patient prognosis.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Perioperative changes in serum amylase levels and their fractions

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients undergoing cardiac surgery

Key exclusion criteria

1) Those who undergo emergency surgery
2) Those who undergo re-operation
3)Patients with past history of pancreatitis and salivary gland inflammation

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Kawashima

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care

Zip code

431-3192

Address

1-20-1 Handayama, Higashi ward, Hamamatsu city, Shizuoka

TEL

053-435-2111

Email

shingogo@hama-med.ac.jp


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Iwata

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care

Zip code

431-3192

Address

1-20-1 Handayama, Higashi ward, Hamamatsu city, Shizuoka

TEL

053-435-2111

Homepage URL


Email

D20004@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Kinoshita Hiroyuki


Funding Source

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi ward, Hamamatsu city, Shizuoka

Tel

053-435-2680

Email

rinri@hama-med.ac.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

2020 Year 09 Month 12 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

Completed

Date of protocol fixation

2020 Year 09 Month 09 Day

Date of IRB

2020 Year 09 Month 03 Day

Anticipated trial start date

2020 Year 09 Month 14 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a prospective observational study of changes in serum amylase levels and fractions during the perioperative period of cardiac surgery.


Management information

Registered date

2020 Year 09 Month 11 Day

Last modified on

2023 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047620


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name