UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030681 |
|---|---|
| Receipt number | 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 18:55:56 |
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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
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
sawadadawasa2004@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035031
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
