UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of septic shock biomakers for the patients with chronic renal failure
Title of the study (Brief title)	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	Junichi Saito
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of anesthesiology
Address	5 zaifucho, Hirosaki, Aomori, Japan
TEL	0172335112
Email	fix-you@hotmail.co.jp

Public contact
Name of contact person	Junichi Saito
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016546