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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036474
Receipt No. R000041565
Scientific Title The potential of circulating peptides as diagnostic agents
Date of disclosure of the study information 2019/05/01
Last modified on 2019/10/16

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Basic information
Public title The potential of circulating peptides as diagnostic agents
Acronym The potential of circulating peptides as diagnostic agents
Scientific Title The potential of circulating peptides as diagnostic agents
Scientific Title:Acronym The potential of circulating peptides as diagnostic agents
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection, these patients need urgent assessment and treatment. Adrenomedullin is a circulating peptide with potent vasodilator activity and is known to be elevated in cardiovascular diseases, inflammatory diseases, and sepsis. The purpose of this study is to investigate the potential of plasma adrenomedullin as a diagnostic biomarker in sepsis, in particular, 1) Comparison of diagnostic ability with current biomarkers (procalcitonin, presepsin, lactate level), 2) Examination about prognosis prediction ability, 3) Usefulness as an index of disease state improvement.
Basic objectives2 Others
Basic objectives -Others The potential of plasma adrenomedullin as a diagnostic biomarker in sepsis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma adrenomedullin level
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 1.Patients 20 years of age or older at the time of consent acquisition
2.The patient who obtained the written consent of the patient himself or his / her representative
Key exclusion criteria Inadequate patients judged by responsible person
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Isao
Middle name
Last name Tsuneyoshi
Organization University of Miyazaki
Division name Department of Anesthesiology
Zip code 889-1692
Address 5200 Kihara, Kiyotaketyou, Miyazaki-city, Miyazaki-Prefecture
TEL 0985-85-9357
Email tetsu_yonaha@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Tetsu
Middle name
Last name Yonaha
Organization Faculty of Medicine, University of Miyazaki Hospital
Division name Intensive Care Unit
Zip code 889-1692
Address 5200 Kihara, Kiyotaketyou, Miyazaki-city, Miyazaki-Prefecture
TEL 0985-85-9357
Homepage URL
Email tetsu_yonaha@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
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 University of Miyazaki Hospital, Clinical Research Support Center
Address 5200 Kihara, Kiyotaketyou, Miyazaki-city, Miyazaki-Prefecture
Tel 0985-85-9403
Email rinken@med.miyazaki-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 O-0317
Org. issuing International ID_1 University of Miyazaki
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 宮崎大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 01 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
2014 Year 10 Month 09 Day
Date of IRB
2014 Year 11 Month 21 Day
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 10 Month 30 Day

Other
Other related information Research Design: Case control study
Patients: From December 2014, consecutive critically ill patients admitted to ICU of University of Miyazaki Hospital.
Measurement item: Plasma adrenomedullin

Management information
Registered date
2019 Year 04 Month 11 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041565

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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