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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041768
Receipt No. 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 2020/09/11

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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 investigate the effects of cardiopulmonary bypass on the elevation of serum amylase levels and the association between these elevations and the prognosis of patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative changes in serum amylase levels and their fractions
Key secondary outcomes Differences in changes in clinical data such as serum amylase levels over time in patients undergoing coronary artery bypass surgery with and without cardiopulmonary bypass
Difference in changes over time in serum amylase levels due to renal function
Percentage of serum amylase fraction
Difference in changes over time in serum amylase levels by type of cardiac surgery
Relationship between serum amylase level and prognosis of patients undergoing cardiac surgery

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
Institute Hamamatsu University School of Medicine
Institute
Department

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 Preinitiation
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
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.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


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