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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015592
Receipt No. R000018119
Scientific Title Increased presepsin (soluble CD14 subtype) values in surgical patients with chronic kidney disease on hemodialysis even in the absence of infection
Date of disclosure of the study information 2014/11/03
Last modified on 2018/11/06

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Basic information
Public title Increased presepsin (soluble CD14 subtype) values in surgical patients with chronic kidney disease on hemodialysis even in the absence of infection
Acronym Presepsin (soluble CD14 subtype) values in surgical patients with chronic kidney disease
Scientific Title Increased presepsin (soluble CD14 subtype) values in surgical patients with chronic kidney disease on hemodialysis even in the absence of infection
Scientific Title:Acronym Presepsin (soluble CD14 subtype) values in surgical patients with chronic kidney disease
Region
Japan

Condition
Condition Surgical patients with chronic kidney disease on hemodialysis in the absence of infection
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Ophthalmology
Dermatology Oto-rhino-laryngology Orthopedics
Urology Oral surgery Neurosurgery
Cardiovascular surgery Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of renal function in the presepsin measurement
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Preoperative presepsin values in the surgical patients with chronic kidney disease on hemodialysis in the absense of infection
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 surgical patients with chronic kidney disease
Interventions/Control_2 surgical patients with normal kidney function
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

Not applicable
Gender Male and Female
Key inclusion criteria surgicak patients with chronic kidney disease on hemodialysis
Key exclusion criteria infectious sign
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Saito
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 5 Zaifu-cho, Hirosaki, Japan
TEL 0172-39-5113
Email fix-you@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Saito
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 5 Zaifu-cho, Hirosaki, Japan
TEL 0172-39-5113
Homepage URL
Email fix-you@hotmail.co.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine, Department of Anesthesiology
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 11 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 03 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018119

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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