UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013816 |
|---|---|
| Receipt number | R000016116 |
| Scientific Title | Intradialytic hypotension prevention by intermittent infusion HDF |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2016/05/01 22:36:00 |
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Basic information
Public title
Intradialytic hypotension prevention by intermittent infusion HDF
Acronym
III study
Scientific Title
Intradialytic hypotension prevention by intermittent infusion HDF
Scientific Title:Acronym
III study
Region
| Japan |
Condition
Condition
Chronic Kidney Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We accumulate I-HDF cases with various IDH (intradyalytic hypotension) and inspect usefulness of the I-HDF therapy by comparing patient's clinical background.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of blood pressure during hemodialysis (including frequency of measures for hypotension)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
# On hemodialysis thrice weekly.
# Frequent intradialytic hypotension episodes (systolic blood pressure drop greater than 20mmHg during HD, or intradialytic hypotensive episode that needs any treatment)
Key exclusion criteria
# Cardiovascular or cerebrovascular event in the last 3 month.
# Obvious inflammatory diseases.
# Obvious and active infective diseases
# Systolic blood pressure rise over 150mmHg during HD.
# On dialyser with membrane area of greater than 2.2 square-meter, or less than 0.8 square-meter.
# On combination therapy with adsorptive device (e.g. Lixcel)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Koda |
Organization
Koda Medical and Dialysis Clinic
Division name
Department of Internal Medicine
Zip code
Address
3748 Yoshida, Tsubame city, Niigata, JAPAN
TEL
0256-92-0001
ykodan@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Koda |
Organization
Koda Medical and Dialysis Clinic
Division name
Department of Internal Medicine
Zip code
Address
3748 Yoshida, Tsubame city, Niigata, JAPAN
TEL
0256-92-0001
Homepage URL
ykodan@gmail.com
Sponsor or person
Institute
Koda Medical and Dialysis Clinic
Institute
Department
Personal name
Funding Source
Organization
Toray Industries, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
甲田内科クリニック（新潟県）
中川内科クリニック（栃木県）
岩淵クリニック（栃木県）
行田総合病院（埼玉県）
久喜総合病院（埼玉県）
小川病院（埼玉県）
柏崎総合医療センター（新潟県）
新潟臨港病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s10157-016-1270-z
Number of participants that the trial has enrolled
Results
Sixty eight patients completed the study. Nine were dropouts. During I-HDF, interventions for symptomatic hypotension were reduced significantly from 4.5 to 3.0 (per person-month, median) and intradialytic systolic blood pressure was 4 mmHg higher on average. The heart rate was lower during I-HDF than HD in the later session. I-HDF could reduce interventions for IDH. It is accompanied with the increased intradialytic blood pressure and the less tachycardia, suggesting less sympathetic stimulation occurs. Thus, I-HDF could be beneficial for some hypotension-prone patients.
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
| 2014 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Frequency and severity of intradialytic hypotension(IDH),
Therapeutic effect of I-HDF for IDH,
Analysis of background-factors of the I-HDF treated patients with respect to effectiveness.
Management information
Registered date
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2016 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016116
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
