UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036474 |
|---|---|
| Receipt number | R000041565 |
| Scientific Title | The potential of circulating peptides as diagnostic agents |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2020/01/09 11:43:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tetsu_yonaha@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041565
