UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037613
Receipt number R000042873
Scientific Title The comparison of circulatory effect of CRRT between AN69ST and polysulphone membrane in patients with septic shock: a retrospective observational study
Date of disclosure of the study information 2019/08/06
Last modified on 2020/04/04 14:42:22

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name