UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015763 |
|---|---|
| Receipt number | R000018344 |
| Scientific Title | The effect of dilution mode of on-line HDF on the intra-dialytic hemodynamic stability |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2023/06/02 14:20:14 |
* 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
The effect of dilution mode of on-line HDF on the intra-dialytic hemodynamic stability
Acronym
EDOIDEA
Scientific Title
The effect of dilution mode of on-line HDF on the intra-dialytic hemodynamic stability
Scientific Title:Acronym
EDOIDEA
Region
| Japan |
Condition
Condition
Chronic kidney disease on dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of pre-dilution on-line HDF uniquely performed in Japan on intradialytic hemodinamics compared with post-dilution HDF commonly performed in the world
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Blood pressure changes during dialysis session
2. Frequency of dialysis related hypotension
3. Frequency of anti-hypotensive measurements
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Crossover as pre-dilution, post-dilution, pre-dilution
Interventions/Control_2
Crossover as post-dilution, pre-dilution, post-dilution
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Dialysis vintage is eaqual or greater than 2 years
2. maintenance dialysis tree times per week and eaqual or greater than 4 hours in each dialysis session
3. Treated with the cathegory 4 dialyzer for hemodialysis patient or treated with on-line HDF
4. Outpatient
5. Without severe dementia
Key exclusion criteria
1. Severe cardiovascular complication or altered cardiac function worse than NYHA3
2. Severe liver dysfunction or AST/ALT as worse as 100IU
3. Respiratory dysfunction treated with oxygen supply
4. non-cured malignant neoplasm
5. patient identified as inappropriate for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | IKUTO |
| Middle name | |
| Last name | MASAKANE |
Organization
YABUKI HOSPITAL
Division name
NEPHROLOGY
Zip code
9900885
Address
4-5-5 Shimakita, Yamagata-shi, Yamagata pref.
TEL
023-682-8566
imasakan.aipod@seieig.or.jp
Public contact
Name of contact person
| 1st name | IKUTO |
| Middle name | |
| Last name | MASAKANE |
Organization
YABUKI HOSPITAL
Division name
NEPHROLOGY
Zip code
9900885
Address
4-5-5 Shimakita, Yamagata-shi, Yamagata pref.
TEL
023-682-8566
Homepage URL
imasakan.aipod@seieig.or.jp
Sponsor or person
Institute
NPO Japanese Society fot Hemodiafiltration
Institute
Department
Personal name
Funding Source
Organization
NPO Japanese Society fot Hemodiafiltration
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
NPO Japanese Society fot Hemodiafiltration
Address
3-30 Nakashimamachi, Tyuo-ku, Hiroshima
Tel
082-243-9191
office@hdf-j.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
| 2014 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
109
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
More time is needed for preparing manuscript.
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
| 2014 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
The paper was not accepted.
Management information
Registered date
| 2014 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018344
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
