UMIN-CTR Clinical Trial

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	Completed
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	2020 Year 01 Month 09 Day

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