UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038028 |
|---|---|
| Receipt number | R000043348 |
| Scientific Title | Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration |
| Date of disclosure of the study information | 2019/09/25 |
| Last modified on | 2019/09/18 11:38:27 |
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Basic information
Public title
Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Acronym
Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Scientific Title
Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Scientific Title:Acronym
Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Region
| Japan |
Condition
Condition
chronic kidney disease/dialysis patient
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Predilution online hemodiafiltration (OHDF) can safely and effectively remove middle- to high-molecular weight uremic substances close to albumin. However, there is a concern that the removal performance of OHDF may deteriorate over time due to the fouling effect caused by the attachment of proteins to the membrane. In recent years, an automated machine called hybrid OHDF which combines intermittent infusion hemodiafiltration (I-HDF) and OHDF has been developed. Since the addition of I-HDF prevents fouling, the amounts of solutes removed may increase compared to OHDF. However, this has not been clarified. In this study, the solute removal performance of hybrid OHDF was compared to that of predilution OHDF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ten patients undergoing chronic maintenance dialysis therapy were included in this study. Four blood purification procedures were performed on the first day of each week's dialysis treatment: predilution OHDF using ABH-22LA (albumin leakage suppression type hemodiafilter), predilution OHDF using ABH-22PA (albumin leakage type hemodiafilter), hybrid OHDF using ABH-22LA, and hybrid OHDF using ABH-22PA. The dialyzed and filtered fluid drained during the 4-h session was collected and the concentrations of urea nitrogen, creatinine, inorganic phosphorus, beta2-microglobulin, alfa 1-microglobulin, and albumin were measured. From these, the removed amount and the clear space of each solute were calculated and were compared in hybrid OHDF and predilution OHDF.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Predilution OHDF (ABH-22PA) >> Washout period (2 hemodialysis) >> Hybrid OHDF (ABH-22PA) >> Washout period (2 hemodialysis) >> Predilution OHDF (ABH-22LA) >> Washout Period (2 hemodialysis) >> Hybrid OHDF (ABH-22LA)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with albumin of 3.5 g/dL or more who have been undergoing chronic maintenance dialysis therapy between March 2019 to April 2019 at the Toujinkai Hospital.
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | suzuki |
Organization
Toujinkai Hospital
Division name
Clinical Engineering
Zip code
612-8026
Address
83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
TEL
075-622-1991
suzuki@tojinkai.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Toujinkai Hospital
Division name
Clinical Engineering
Zip code
612-8026
Address
83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
TEL
075-622-1991
Homepage URL
suzuki@tojinkai.jp
Sponsor or person
Institute
Division of Clinical Engineering, Toujinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Toujinkai Hospital
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
Toujinkai Hospital
Address
83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
Tel
075-622-1991
suzuki@tojinkai.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 | 09 | Month | 25 | 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
In the treatments that used ABH-22LA, hybrid OHDF removed significantly more and had larger alfa 1-microglobulin clear space than pre-dilution OHDF. In the treatments that used ABH-22PA, hybrid OHDF removed significantly more and had larger beta 2-microglobulin, alfa 1-microglobulin, and albumin clear spaces than predilution OHDF.
Results date posted
| 2019 | Year | 09 | Month | 17 | Day |
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 | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043348
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