UMIN-CTR Clinical Trial

Basic information
Public title	The comparison of circulatory effect of CRRT between AN69ST and polysulphone membrane in patients with septic shock: a retrospective observational study
Acronym	AN69ST membrane for septic shock
Scientific Title	The comparison of circulatory effect of CRRT between AN69ST and polysulphone membrane in patients with septic shock: a retrospective observational study
Scientific Title:Acronym	AN69ST membrane for septic shock
Region	Japan

Condition
Condition	Septic shock
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The acrylonitrile-co-methallyl sulfonate surface-treated (AN69ST) membrane is expected to improve hemodynamics in patients with sepsis by cytokine adsorption. However, the clinical literature on AN69ST membranes is scarce. The aim of this study is to reveal whether AN69ST membrane improves the circulation of patients with septic shock.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the vasopressor dependency index during the 12 hours after the start of CRRT.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	18 years of age or older who required CRRT for septic shock.
Key exclusion criteria	patients who died within 24 hours after starting CRRT, were treated by direct hemoperfusion therapy with polymyxin B immobilized fiber cartridges (PMX-DHP), were treated by extracorporeal membrane oxygenation (ECMO) and were dialyzed by other membranes than PS and AN69ST for CRRT.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Mami Middle name Last name Shibata
Organization	Wakayama Medical University
Division name	Department of Emergency and Critical Care Medicine
Zip code	6418509
Address	811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL	0734410603
Email	mami517@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Mami Middle name Last name Shibata
Organization	Wakayama Medical University
Division name	Department of Emergency and Critical Care Medicine
Zip code	6418509
Address	811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL	0734410603
Homepage URL
Email	mami517@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
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	IRB of WMU
Address	Wakayama
Tel	0734410603
Email	eccm@wakayama-med.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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 06 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/abs/10.1111/1744-9987.13462
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
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	2019 Year 08 Month 02 Day
Date of IRB	2019 Year 08 Month 02 Day
Anticipated trial start date	2019 Year 08 Month 02 Day
Last follow-up date	2019 Year 08 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retorospective observational study

Management information
Registered date	2019 Year 08 Month 06 Day
Last modified on	2020 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042873