UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040565 |
|---|---|
| Receipt number | R000046303 |
| Scientific Title | Prospective observational study on cytokine removal in continuous hemodiafiltration |
| Date of disclosure of the study information | 2020/05/28 |
| Last modified on | 2024/05/31 13:03:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective observational study on cytokine removal in continuous hemodiafiltration
Acronym
Prospective observational study on cytokine removal in continuous hemodiafiltration
Scientific Title
Prospective observational study on cytokine removal in continuous hemodiafiltration
Scientific Title:Acronym
Prospective observational study on cytokine removal in continuous hemodiafiltration
Region
| Japan |
Condition
Condition
Patients who started continuous hemodiafiltration
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the cytokine removal effect of CHDF
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in various blood cytokine levels 2, 18 and 24 hours after the start of CHDF
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with written or verbal consent
Key exclusion criteria
Patients who the investigator determined to be inappropriate as subjects
(Patients who deviate from the dialysis conditions [dialysis fluid 0.4 L / hour, replacement fluid 0.4 L / hour], who also use endotoxin adsorption therapy, who need to change the purification membrane within 24 hours of CHDF start, and within 24 hours. Those who have completed CHDF)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Nakata |
Organization
Juntendo University Hospital
Division name
Department of Nephrology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo JAPAN
TEL
03-3813-3111
jnakata@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Nakata |
Organization
Juntendo University Hospital
Division name
Department of Nephrology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo JAPAN
TEL
03-3813-3111
Homepage URL
jnakata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Ethics Committee of Juntendo University Hospital
Address
3-1-3 Hongo Bunkyo-ku, Tokyo JAPAN
Tel
03-3813-3111
kenkyu5858@juntendo.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
| 2020 | Year | 05 | Month | 28 | 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
10
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
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 05 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046303
