UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021225 |
|---|---|
| Receipt number | R000024486 |
| Scientific Title | Effects of continous plasma filtration with dialysis therapy in severe septic patients with acute liver failure |
| Date of disclosure of the study information | 2016/02/27 |
| Last modified on | 2020/03/13 14:41:46 |
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Basic information
Public title
Effects of continous plasma filtration with dialysis therapy in severe septic patients with acute liver failure
Acronym
Effects of CPDF in severe septic patients with acute liver failure
Scientific Title
Effects of continous plasma filtration with dialysis therapy in severe septic patients with acute liver failure
Scientific Title:Acronym
Effects of CPDF in severe septic patients with acute liver failure
Region
| Japan |
Condition
Condition
severe sepsis with acute liver failure
Classification by specialty
| Gastroenterology | Infectious disease | Hepato-biliary-pancreatic surgery |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the effects of CPDF therapy in severe septic patients with acute liver failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Changes in the severity score (APACHE II and SOFA) at 5 days after CPDF therapy
Key secondary outcomes
Duration of ICU stay, duration of hospitality, survival rate at 28day after CPDF therapy, and changes in hemodynamics and respiratory function and biochemical data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
CPDF therapy (+)
It is possible to treat CPDF therapy for 7 days.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with both the criteria of sepsis and the criteria of acute liver failure.
Sepsis is defined as SIRS with infection.
Acute liver failure is defined as PT 40% or PT-INR >1,5 within 8 weeks.
Key exclusion criteria
1) During pregnancy or breast-feeding
2) The doctor has been deemed inappropriate
3) Not obtain consent from the patient or families
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takumi Taniguchi |
Organization
Kanazawa University Hospital
Division name
Intensive Care Unit
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2430
ttaniyan@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takumi Taniguchi |
Organization
Kanazawa University Hospital
Division name
Intensive Care Unit
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2430
Homepage URL
ttaniyan@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Intensive Care Unit, Kanazawa University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 27 | 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
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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024486
