UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Title of the study (Brief title)	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	Yu Sawada
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL	045-787-2650
Email	t116036e@yokohama-cu.ac.jp

Public contact
Name of contact person	Yu Sawada
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL	045-787-2650
Homepage URL
Email	t116036e@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Department of Gastroenterological Surgery
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031917