UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sepsis-3 based evaluation of living donor liver transplantation: risk factor of sepsis onset and predictive factor of poor prognosis
Title of the study (Brief title)	Sepsis-3 based evaluation of living donor liver transplantation: risk factor of sepsis onset and predictive factor of poor prognosis
Region	Japan

Condition
Condition	Patient at our hospital after living liver transplant surgery
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to clarify the risk factors of sepsis after LDLT on the basis of Sepsis-3 and the predictive factors of poor prognosis after the sepsis onset.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the risk factors of sepsis after LDLT on the basis of Sepsis-3 and the predictive factors of poor prognosis after the sepsis onset.
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	13 years-old <
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent LDLT at our hospital between November 1997 and January 2017.
Key exclusion criteria	None
Target sample size	64

Research contact person
Name of lead principal investigator	Sawada Yu
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery,
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2800
Email	sawadadawasa2004@yahoo.co.jp

Public contact
Name of contact person	Sawada Yu
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery,
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2650
Homepage URL
Email	sawadadawasa2004@yahoo.co.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 01 Month 05 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 19 Day
Anticipated trial start date	2018 Year 01 Month 05 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	Unpublished
URL releasing results
Results
Other related information	Preoperative factors, intraoperative factors and postoperative factors will be examined in the group with sepsis combined vs noncompliant group. We will also consider pathogenic bacteria and infected organs. We also compare the prognosis of nonseptic sepsis group and sepsis group.

Management information
Registered date	2018 Year 01 Month 04 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035031