UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059366 |
|---|---|
| Receipt number | R000067898 |
| Scientific Title | Comparison of the effects of polysulfone and cellulose triacetate membranes on circuit lifespan in continuous renal replacement therapy: A non-randomized controlled trial |
| Date of disclosure of the study information | 2025/10/11 |
| Last modified on | 2025/10/10 12:43:32 |
* 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
Comparison of circuit lifespan between polysulfone and cellulose triacetate membranes during continuous renal replacement therapy
Acronym
Comparative study of hemodialysis membranes
Scientific Title
Comparison of the effects of polysulfone and cellulose triacetate membranes on circuit lifespan in continuous renal replacement therapy: A non-randomized controlled trial
Scientific Title:Acronym
A non-randomized comparative study on circuit lifespan between polysulfone and cellulose triacetate membranes
Region
| Japan |
Condition
Condition
cute kidney injury (AKI) or chronic kidney disease (CKD), including end-stage renal disease (ESRD), requiring continuous renal replacement therapy (CRRT)
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, five types of hemofilter membrane materials are currently available for continuous renal replacement therapy (CRRT). Each membrane material has unique characteristics, and clinicians may select them according to the patient's disease and clinical condition. One of the key considerations in membrane selection is the potential to extend circuit lifespan. CRRT is performed continuously over 24 hours; however, the replacement interval of the circuit, including the hemofilter, varies among institutions, typically every 24 or 48 hours. When circuits are used beyond 24 hours, membranes with higher antithrombogenic properties are preferred. Cellulose triacetate (CTA) membranes are known for their antithrombogenic properties, but evidence supporting their contribution to prolonged circuit lifespan remains limited. Therefore, we conducted a non-randomized comparative study at our institution to evaluate the effect of membrane material on circuit lifespan. Polysulfone (PS) membranes, which are the most commonly used in CRRT in Japan, were selected as the comparator.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study was the cumulative circuit survival rate at 48 hours, analyzed using the Kaplan-Meier method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Device,equipment |
Interventions/Control_1
For patients requiring CRRT, hemofilters with cellulose triacetate (CTA) membranes were used for the first and second day of treatment.
Interventions/Control_2
For patients requiring CRRT, hemofilters with polysulfone (PS) membranes were used for the first and second day of treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population consisted of patients admitted to the intensive care unit of our hospital between June 2023 and September 2024, for whom the attending intensivist or primary physician determined that continuous renal replacement therapy (CRRT) was required.
Key exclusion criteria
Patients meeting any of the following criteria were excluded from the study:
Presence of significant coagulation abnormalities due to hematologic disorders.
Use of a hemofilter other than the assigned membrane material during the first or second CRRT session.
Circuit clotting caused by prolonged troubleshooting, such as device malfunction or inadequate blood flow.
Missing data regarding patient background or CRRT treatment conditions.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Shimomura |
Organization
Japanese Red Cross Osaka Hospital
Division name
Department of Clinical Engineering
Zip code
5438555
Address
5-30 Fudegasaki-cho, Tennoji-ku, Osaka-shi, Osaka , Japan
TEL
0667745111
taroumail1978@yahoo.co.jp
Public contact
Name of contact person
| 1st name | taro |
| Middle name | |
| Last name | shimomura |
Organization
Japanese Red Cross Osaka Hospital
Division name
Department of Clinical Engineering
Zip code
5438555
Address
5-30 Fudegasaki-cho, Tennoji-ku, Osaka-shi, Osaka , Japan
TEL
0667745111
Homepage URL
taroumail1978@yahoo.co.jp
Sponsor or person
Institute
Japanese Red Cross Osaka Hospital
Institute
Department
Personal name
Taro Shimomura
Funding Source
Organization
None
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
Japanese Red Cross Osaka Hospital
Address
5-30 Fudegasaki-cho, Tennoji-ku, Osaka-shi, Osaka , Japan
Tel
0667745111
hospital@osaka-med.jrc.or.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
| 2025 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.osaka-med.jrc.or.jp/assets/pdf/ethics/ethics-j_03.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.credoinc.jp/jsbpcc36/PDF/program_jsbpcc36.pdf
Number of participants that the trial has enrolled
69
Results
There were no significant differences in underlying diseases between the two groups. Baseline characteristics, including sex, severity, and coagulation-related laboratory data, showed no significant differences between the groups.The primary endpoint, cumulative circuit survival rate at 48 hours, was 52.4% in the PS group and 52.9% in the CTA group, with no significant difference (P = 0.72).
Results date posted
| 2025 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Disease background
CTA group: Sepsis 25.0%, Respiratory failure 20.8%, Post-cardiac surgery 12.5%
PS group: Sepsis 20.8%, Respiratory failure 25.0%, Post-cardiac surgery 12.5%
Baseline characteristics
CTA group: Age 69.0 [65.0-76.3] years; Male 13 (79.2%); Body weight 64.5 [55.5-81.1] kg; APACHE II 27.5 [22.0-36.0]; SOFA 12.5 [9.0-14.0]; Hematocrit 29.5 [25.7-32.5] %; DIC score 3.0 [1.8-4.3]; ICU length of stay 15.5 [8.3-30.8] days; 28-day mortality 6 (25.0%)
PS group: Age 70.0 [62.5-78.0] years; Male 13 (54.2%); Body weight 62.8 [57.5-76.7] kg; APACHE II 32.5 [25.8-36.5]; SOFA 11.0 [8.8-13.3]; Hematocrit 29.1 [24.8-36.0] %; DIC score 3.0 [2.0-4.0]; ICU length of stay 12.5 [10.0-16.3] days; 28-day mortality 3 (12.5%)
Participant flow
Of the 91 eligible patients during the study period, 69 were enrolled. The PS allocation period started on June 1, 2023. Of the 32 patients assigned to the PS group, 8 were excluded, leaving 24 patients for the final analysis. The CTA allocation period started on December 1, 2023. Of the 37 patients assigned to the CTA group, 13 were excluded, leaving 24 patients for the final analysis.
Adverse events
No adverse events were observed during the study.
Outcome measures
During the study period, 91 patients met the eligibility criteria, of whom 22 patients who did not undergo circuit replacement were excluded, leaving 69 patients for registration. During the PS group data collection period, 8 patients were excluded, 7 due to the use of non-assigned hemofilters, and 1 due to missing data on CRRT treatment conditions. During the CTA group data collection period, 13 patients were excluded, all due to the use of non-assigned hemofilters.
There were no significant differences in underlying diseases between the two groups. Both groups had high proportions of respiratory failure and sepsis, which together accounted for approximately half of the patients. Baseline characteristics, including sex, severity, and coagulation-related laboratory data, showed no significant differences between the groups.
The primary endpoint, cumulative circuit survival rate at 48 hours, was 52.4% in the PS group and 52.9% in the CTA group, with no significant difference (P = 0.72). Regarding the secondary endpoint of clotting sites, the PS group predominantly experienced clotting in the venous chamber, whereas the CTA group predominantly experienced clotting in the hemofilter (P < 0.01).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067898
