UMIN-CTR Clinical Trial

Basic information
Public title	Effects of continous plasma filtration with dialysis therapy in severe septic patients with acute liver failure
Acronym	Effects of CPDF in severe septic patients with acute liver failure
Scientific Title	Effects of continous plasma filtration with dialysis therapy in severe septic patients with acute liver failure
Scientific Title:Acronym	Effects of CPDF in severe septic patients with acute liver failure
Region	Japan

Condition
Condition	severe sepsis with acute liver failure
Classification by specialty	Gastroenterology Infectious disease Hepato-biliary-pancreatic surgery Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluated the effects of CPDF therapy in severe septic patients with acute liver failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Changes in the severity score (APACHE II and SOFA) at 5 days after CPDF therapy
Key secondary outcomes	Duration of ICU stay, duration of hospitality, survival rate at 28day after CPDF therapy, and changes in hemodynamics and respiratory function and biochemical data

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	CPDF therapy (+) It is possible to treat CPDF therapy for 7 days.
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with both the criteria of sepsis and the criteria of acute liver failure. Sepsis is defined as SIRS with infection. Acute liver failure is defined as PT 40% or PT-INR >1,5 within 8 weeks.
Key exclusion criteria	1) During pregnancy or breast-feeding 2) The doctor has been deemed inappropriate 3) Not obtain consent from the patient or families
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takumi Taniguchi
Organization	Kanazawa University Hospital
Division name	Intensive Care Unit
Zip code
Address	13-1 Takara-machi, Kanazawa
TEL	076-265-2430
Email	ttaniyan@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takumi Taniguchi
Organization	Kanazawa University Hospital
Division name	Intensive Care Unit
Zip code
Address	13-1 Takara-machi, Kanazawa
TEL	076-265-2430
Homepage URL
Email	ttaniyan@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Intensive Care Unit, Kanazawa University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	金沢大学附属病院（石川県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 27 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	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
Date of IRB	2015 Year 04 Month 23 Day
Anticipated trial start date	2016 Year 02 Month 27 Day
Last follow-up date	2018 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 27 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024486