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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035290
Receipt No. R000040205
Scientific Title Evaluation of Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter Using Waste Liquid of Continuous Renal Replacement Therapy
Date of disclosure of the study information 2018/12/18
Last modified on 2018/12/17

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Basic information
Public title Evaluation of Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter Using Waste Liquid of Continuous Renal Replacement Therapy
Acronym Evaluation of Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter Using Waste Liquid of Continuous Renal Replacement Therapy
Scientific Title Evaluation of Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter Using Waste Liquid of Continuous Renal Replacement Therapy
Scientific Title:Acronym Evaluation of Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter Using Waste Liquid of Continuous Renal Replacement Therapy
Region
Japan

Condition
Condition Acute kidney disease due to sepsis
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cytokine Removal Performance of Sustained Gradual Hemodynamic Filter
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Sampling of wasted liquid of continuous renal replacement therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Acute Kidney Disease Patient
(2)CRRT patient after surgery
(3)The patients judged the necessity of CRRT by their doctor
Key exclusion criteria 1)The setting of CRRT is inappropriate
2)Inappropriate of induction of CRRT due to hemorrhages
3)Anaphylaxis due to CRRT
4)Pregnancy
5)Other clinical trial participants
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinischi Nishi
Organization Hyogo College of Medicine
Division name Intensive Care Unit
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya-city, Hyogo, Japan
TEL 0798-45-6389
Email shinitch@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ide
Organization Hyogo College of Medicine
Division name Intensive Care Unit
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya-city, Hyogo, Japan
TEL 0798-45-6389
Homepage URL
Email tide7977@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 18 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 17 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040205

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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