UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033778 |
|---|---|
| Receipt number | R000038466 |
| Scientific Title | Effect of hemoperfusion with hexadecyl-immobilized cellulose beads on myocardial fatty acid imaging in hemodialysis patients: a case series study |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/02/04 21:33:02 |
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Basic information
Public title
Effect of hemoperfusion with hexadecyl-immobilized cellulose beads on myocardial fatty acid imaging in hemodialysis patients: a case series study
Acronym
Effect of hemoperfusion with hexadecyl-immobilized cellulose beads on myocardial fatty acid imaging in hemodialysis patients
Scientific Title
Effect of hemoperfusion with hexadecyl-immobilized cellulose beads on myocardial fatty acid imaging in hemodialysis patients: a case series study
Scientific Title:Acronym
Effect of hemoperfusion with hexadecyl-immobilized cellulose beads on myocardial fatty acid imaging in hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hexadecyl immobilized in porous cellulose beads (HICBs) with an appropriate pore size and a mean diameter of 460 mm in a column (Lixelle; Kaneka Medix Co) were originally designed to selectively adsorb beta 2-microglobulin (B2-MG) through hydrophobic interactions. Several reports suggested that the Lixelle column removes not only B2-MG but also several inflammatory cytokines and free protein-binding uremic toxins (PBUTs). Dialysis patients are in a chronic activated inflammatory state as demonstrated by both elevated inflammation markers and proinflammatory cytokines, such as Interleukin-6 (IL-6). Recently, the levels of IL-6 have been found to have a strong correlation with both total and cardiovascular mortality in hemodialysis patients. Furthermore, PBUTs also accumulate in hemodialysis patients, and high circulating levels of these toxins were reported to be associated with chronic kidney disease-related complications, including cardiovascular disease.
Cardiac deaths account for the high mortality of hemodialysis patients. We have shown that impaired myocardial fatty acid metabolism assessed by single-photon emission computed tomography (SPECT) using 123I-B-methyliodophenyl pentadecanoic acid (BMIPP) is likely to be associated with cardiac death in hemodialysis patients. This predictive potential of BMIPP SPECT for cardiac death in hemodialysis patients was identified in a multicenter cohort study in Japan. The purpose of this retrospective study is to clarify whether direct hemoperfusion with HICBs improves the impaired myocardial fatty acid imaging in hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Hemodialysis patients who had been treated with HICB columns for more than 4 years are assigned to the HICBs group, while the other patients were assigned to the non-HICBs group.
All patients taked two BMIPP SPECTs at intervals of more than 3 years. The images were divided into 17 segments for semiquantitative analysis according to the standard myocardial segmentation for tomographic heart imaging established by the American Heart Association. The amount of radioactivity taken up by each segment was visually graded and assigned an uptake score of either 0 (normal), 1 (mildly reduced), 2 (moderately reduced), 3 (severely reduced), or 4 (none). The BMIPP SPECT scores for 17 myocardial segments were designated as the BMIPP summed score (SS). We compared first and second BMIPP SPECT SS in HICBs group and non-HICBs group.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria for enrollment in this study were as follows; (1) patients on dialysis for 10 years or more, (2) at least 3 years between the first and second BMIPP SPECT (Observation period). Among them, patients who treated HICB column for more than 4 years were assigned to HICBs group. Patients who had never been treated with HICBs column were assigned to non-HICBs group.
Key exclusion criteria
Patients who received percutaneous coronary intervention or coronary artery bypass grafting during the observation period.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Suzuki |
Organization
Toujinkai Hospital
Division name
Clinical Engineering
Zip code
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 | |
| Middle name | |
| Last name | Naoki Suzuki |
Organization
Toujinkai Hospital
Division name
Clinical Engineering
Zip code
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
Division of Clinical engineering, Toujinkai Hospital
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The HICBs group showed a lower mean B2-MG than that of the non-HICBs group, while other clinical baseline patient characteristics did not differ between the HICBs and the non-HICBs groups. In the HICB group, the 2nd BMIPP SS was significantly decreased compared to that for the 1st BMIPP SS. A decrease in the BMIPP SS was observed in 9 (75%) patients with 1st BMIPP SS >= 6, and no change was observed in 3 patients with BMIPP SS <= 2. In the non-HICBs group, the 2nd BMIPP SS was significantly increased compared to that for the 1st BMIPP SS.
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 15 | Day |
Other
Other related information
Twenty-four hemodialysis patients in the Toujinkai group met the eligibility criteria between April 1st 2010 and December 31th 2017. Among them, 12 patients who had had been treated with HICB columns for more than 4 years were assigned to the HICBs group (mean observation period: 61.9 +- 16.3 months), while the other patients were assigned to the non-HICBs group (mean observation period: 58.0 +- 12.2 months).
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038466
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