UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005621 |
|---|---|
| Receipt number | R000006641 |
| Scientific Title | A trial of low-efficient hemofiltration and hemodialysis in the intracranial hypertension of acute phase in hemodialysis patients |
| Date of disclosure of the study information | 2012/05/19 |
| Last modified on | 2014/05/20 15:33:05 |
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Basic information
Public title
A trial of low-efficient hemofiltration and hemodialysis in the intracranial hypertension of acute phase in hemodialysis patients
Acronym
A trial of low-efficient hemofiltration and hemodialysis in the intracranial hypertension
Scientific Title
A trial of low-efficient hemofiltration and hemodialysis in the intracranial hypertension of acute phase in hemodialysis patients
Scientific Title:Acronym
A trial of low-efficient hemofiltration and hemodialysis in the intracranial hypertension
Region
| Japan |
Condition
Condition
intracranial hypertension
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of low-efficient haemodialysis and hemofiltration in the acute phase of the intracranial hypertension in hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival rate, state of consciousness, blood pressure in the dialysis session, osmolality, blood urea nitrogen concentration and bicarbonate concentration before and after the dialysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
| Maneuver |
Interventions/Control_1
low-efficient hemodialysis
Interventions/Control_2
low-efficient hemofiltration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemodialysis patients, intracranial hypertension in acute phase
Key exclusion criteria
shock
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Okada |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emi Seki |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
Homepage URL
kokada@med.nihon-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Itabashi Hospital, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2012 | Year | 05 | Month | 19 | 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
| 2012 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | 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
| 2011 | Year | 05 | Month | 19 | Day |
Last modified on
| 2014 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006641
