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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028025 |
Receipt No. | R000032090 |
Scientific Title | Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study) |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2019/03/28 |
Basic information | ||
Public title | Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study) | |
Acronym | Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study) | |
Scientific Title | Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study) | |
Scientific Title:Acronym | Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study) | |
Region |
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Condition | |||
Condition | burn, severe acute pancreatitis, sepsis | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the clinical effects of continuous hemodiafiltration between using PMMA and AN69ST membrane hemofilter for the treatment of septic AKI. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | -Changes of scores (SOFA, SAPS2, APACHE2, DIC score, CAI) at 48 and 72 hours after enrollment |
Key secondary outcomes | -Duration of mechanical ventilation in 28 days
-Survival rate at 90 days -ICU stay days -Hospital stay days -Changes of plasma lactate and IL-6 level at 72 hours after continuous hemodiafiltration -Filter lifetime -Total fluid volume |
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 |
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Interventions/Control_1 | Continuous hemodiafiltration using PMMA membrane hemofilter | |
Interventions/Control_2 | Continuous hemodiafiltration using AN69ST membrane hemofilter | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | ->=20 years of age
-Able and willing to provide informed consent -Patients with burn, severe acute pancreatitis or sepsis -Patients with KDIGO stage 1 screened -Patients who require continuous hemodiafiltration for more than 24 hours |
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Key exclusion criteria | -Pregnant women
-Patients with chronic kidney disease or who received RRT before randomization -Patients with terminal cancer -Patients with body weight less than 30 kg -Patients considered ineligible for the study by the investigator |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Faculty of Medicine, Saga University | ||||||
Division name | Department of Emergency and Critical Care Medicine | ||||||
Zip code | 849-8501 | ||||||
Address | 5-1-1 Nabeshima, Saga City, Saga | ||||||
TEL | 0952-31-6511 | ||||||
sr0737@cc.saga-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Faculty of Medicine, Saga University | ||||||
Division name | Department of Emergency and Critical Care Medicine | ||||||
Zip code | 849-8501 | ||||||
Address | 5-1-1 Nabeshima, Saga City, Saga | ||||||
TEL | 0952-31-6511 | ||||||
Homepage URL | |||||||
sr0737@cc.saga-u.ac.jp |
Sponsor | |
Institute | Saga University |
Institute | |
Department |
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 | Clinical research center, Saga University Hospital |
Address | 5-1-1 Nabeshima, Saga City, Saga |
Tel | 0952-34-3400 |
clinstudycenter@mail.admin.saga-u.ac.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 | 佐賀大学医学部附属病院(佐賀県)、唐津赤十字病院(佐賀県)、独立行政法人国立病院機構 嬉野医療センター(佐賀県)、佐賀県医療センター好生館(佐賀県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032090 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |