UMIN-CTR Clinical Trial

Basic information
Public title	Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Acronym	Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Scientific Title	Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Scientific Title:Acronym	Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Region	Japan

Condition
Condition	burn, severe acute pancreatitis, sepsis
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the clinical effects of continuous hemodiafiltration between using PMMA and AN69ST membrane hemofilter for the treatment of septic AKI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Changes of scores (SOFA, SAPS2, APACHE2, DIC score, CAI) at 48 and 72 hours after enrollment
Key secondary outcomes	-Duration of mechanical ventilation in 28 days -Survival rate at 90 days -ICU stay days -Hospital stay days -Changes of plasma lactate and IL-6 level at 72 hours after continuous hemodiafiltration -Filter lifetime -Total fluid volume

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Continuous hemodiafiltration using PMMA membrane hemofilter
Interventions/Control_2	Continuous hemodiafiltration using AN69ST membrane hemofilter
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	Not applicable
Gender	Male and Female
Key inclusion criteria	->=20 years of age -Able and willing to provide informed consent -Patients with burn, severe acute pancreatitis or sepsis -Patients with KDIGO stage 1 screened -Patients who require continuous hemodiafiltration for more than 24 hours
Key exclusion criteria	-Pregnant women -Patients with chronic kidney disease or who received RRT before randomization -Patients with terminal cancer -Patients with body weight less than 30 kg -Patients considered ineligible for the study by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sakurai
Organization	Faculty of Medicine, Saga University
Division name	Department of Emergency and Critical Care Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga City, Saga
TEL	0952-31-6511
Email	sr0737@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sakurai
Organization	Faculty of Medicine, Saga University
Division name	Department of Emergency and Critical Care Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga City, Saga
TEL	0952-31-6511
Homepage URL
Email	sr0737@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Toray Industries, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical research center, Saga University Hospital
Address	5-1-1 Nabeshima, Saga City, Saga
Tel	0952-34-3400
Email	clinstudycenter@mail.admin.saga-u.ac.jp

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	佐賀大学医学部附属病院（佐賀県）、唐津赤十字病院（佐賀県）、独立行政法人国立病院機構　嬉野医療センター（佐賀県）、佐賀県医療センター好生館（佐賀県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 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	Completed
Date of protocol fixation	2016 Year 05 Month 02 Day
Date of IRB	2016 Year 05 Month 02 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2019 Year 03 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 30 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032090

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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