UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020375 |
|---|---|
| Receipt number | R000023330 |
| Scientific Title | Risk factors of sepsis a after liver transplantation; retrospective study |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2015/12/28 11:24:17 |
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Basic information
Public title
Risk factors of sepsis a after liver transplantation; retrospective study
Acronym
Risk factors of sepsis a after liver transplantation; retrospective study
Scientific Title
Risk factors of sepsis a after liver transplantation; retrospective study
Scientific Title:Acronym
Risk factors of sepsis a after liver transplantation; retrospective study
Region
| Japan |
Condition
Condition
Living Donor liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the perioperative factor between sepsis onset group and non-sepsis group within postoperative 90 days, postoperative sepsis after living donor liver transplantation in our hospital, in particular, to clarify the risk factors for severe sepsis
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative factor
Gender, age, bd glucan positive rate, ABO incompatibility rate, Body mass index, renal function, PT-INR, T-BIL, Albumin
Lymphocyte count, respiratory function
Intraoperative factor
Surgery time, amount of bleeding, splenectomy rate, intraoperative transfusion amount, graft size, portal pressure
Postoperative factor
Surgery immediately after oxygenation, cytomegalovirus infection rate, acute rejection incidence, hospital death rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Liver transplantation patients 64 cases that were enforced in our hospital until October 2015 than in November 1997. It includes a re-transplant one cases
Key exclusion criteria
Exclusion criteria
None
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takeda |
Organization
Yokohama City University
Division name
Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, Japan
TEL
045-787-2800
kazutake@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takeda |
Organization
Yokohama City University
Division name
Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, Japan
TEL
045-787-2800
Homepage URL
kazutake@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
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
| 2016 | Year | 01 | Month | 01 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2015 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023330
