UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027856 |
|---|---|
| Receipt number | R000031917 |
| Scientific Title | A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation |
| Date of disclosure of the study information | 2017/06/21 |
| Last modified on | 2017/06/21 21:42:07 |
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Basic information
Public title
A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Acronym
A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Scientific Title
A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Scientific Title:Acronym
A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Region
| Japan |
Condition
Condition
A blood type incompatible living liver transplant patient
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors of postoperative sepsis after ABO-incompatible living liver transplantation at our hospital.
Basic objectives2
Others
Basic objectives -Others
Perioperative factors are compared
between septic-onset group and non-sepsis group within 90 days after surgery. In this study, sepsis was referred to "International consensus definition of sepsis and septic shock Third Edition". That is, it was defined as an infection with an increase of 2 or more SOFA scores. Infections were defined based on criteria proposed by centers for disease prevention and prevention and reports on liver transplant related in the past. In addition, sepsis was compared with perioperative factors in the sepsis group and the non-sepsis group by referring to the above guidelines of sepsis, and the risk factors were examined.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Classified the subject cases into septic
onset group and non-onset group, and
compared the perioperative factors in both groups to examine risk factors for 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ABO-I-LT between November 1997 and March 2016 at our department.
Key exclusion criteria
None
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Sawada |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
045-787-2650
t116036e@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Sawada |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
045-787-2650
Homepage URL
t116036e@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 06 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study at a single facility using existing medical record information.
Management information
Registered date
| 2017 | Year | 06 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031917
