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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014208
Receipt No. R000016546
Scientific Title Efficacy of septic shock biomakers for the patients with chronic renal failure
Date of disclosure of the study information 2014/06/10
Last modified on 2018/11/06

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Basic information
Public title Efficacy of septic shock biomakers for the patients with chronic renal failure
Acronym Chronic renal failure and septic shock biomarker
Scientific Title Efficacy of septic shock biomakers for the patients with chronic renal failure
Scientific Title:Acronym Chronic renal failure and septic shock biomarker
Region
Japan

Condition
Condition chronic renal failure
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
Plastic surgery Operative medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of renal dysfunction to sepsitic shock marker measurement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cut off value of Presepsin (soluble CD14) for the patients with chronic renal failure
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
80 years-old >
Gender Male and Female
Key inclusion criteria Chronic renal failure
Key exclusion criteria suspicious of infectious patient
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 zaifucho, Hirosaki, Aomori, Japan
TEL 0172335112
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 zaifucho, Hirosaki, Aomori, Japan
TEL 0172335112
Homepage URL
Email fix-you@hotmail.co.jp

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

Funding Source
Organization Department of Anesthesiology, Hirosaki University Graduate School of Medicine
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 06 Month 10 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 05 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information measurements of septic shock marker for the patients with chronic renal failure in just after induction of anesthesia, just after finishing of operation and postoperative day 1

Management information
Registered date
2014 Year 06 Month 09 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=R000016546

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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