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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030681
Receipt No. R000035031
Scientific Title Sepsis-3 based evaluation of living donor liver transplantation: risk factor of sepsis onset and predictive factor of poor prognosis
Date of disclosure of the study information 2018/01/05
Last modified on 2018/01/04

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Basic information
Public title Sepsis-3 based evaluation of living donor liver transplantation:
risk factor of sepsis onset and predictive factor of poor prognosis
Acronym Sepsis-3 based evaluation of living donor liver transplantation:
risk factor of sepsis onset and predictive factor of poor prognosis
Scientific Title Sepsis-3 based evaluation of living donor liver transplantation:
risk factor of sepsis onset and predictive factor of poor prognosis
Scientific Title:Acronym 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
1st name
Middle name
Last name Sawada Yu
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterological Surgery,
Zip code
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
1st name
Middle name
Last name Sawada Yu
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterological Surgery,
Zip code
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)

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
2018 Year 01 Month 05 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 19 Day
Date of IRB
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

Other
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

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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