UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015937 |
|---|---|
| Receipt number | R000017965 |
| Scientific Title | Optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2017/03/23 21:04:32 |
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Basic information
Public title
Optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome
Acronym
Optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome
Scientific Title
Optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome
Scientific Title:Acronym
Optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome
Region
| Japan |
Condition
Condition
Dialysis disequilibrium syndrome
Classification by specialty
| Medicine in general | Nephrology | Neurology |
| Ophthalmology | Radiology | Neurosurgery |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of ultrasonographic optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome in patients undergoing first-time dialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity of ultrasonographic optic nerve sheath diameter of patients undergoing first-time dialysis for the detection of dialysis disequilibrium syndrome will be calculated.
Receiver operator characteristic curve will be constructed to determine the optimal ultrasonographic optic nerve sheath diameter cut-off point to detect dialysis disequilibrium syndrome in patients undergoing first-time dialysis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo their first-time dialysis at Hyogo Prefectural Amagasaki Hospital
Key exclusion criteria
Patient who can not communicate
Intubated patient
Patients who can not report their headache or nausea
Patients who have known intracranial expanding lesion
Patient disagree with participation to the study
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIraku Tsujimoto |
Organization
Hyogo Prefectural Amagasaki Hospital
Division name
Department of Nephrology
Zip code
Address
1-1, Higashidaimotsu-cho 1-chome, Amagasaki, Hyogo, Japan
TEL
06-6482-1521
hira_to_ber3598@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIraku Tsujimoto |
Organization
Hyogo Prefectural Amagasaki Hospital
Division name
Department of Nephrology
Zip code
Address
1-1, Higashidaimotsu-cho 1-chome, Amagasaki, Hyogo, Japan
TEL
06-6482-1521
Homepage URL
hira_to_ber3598@yahoo.co.jp
Sponsor or person
Institute
Department of Nephrology, Hyogo Prefectural Amagasaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Hyogo Prefectural Amagasaki Hospital
Organization
Division
Category of Funding Organization
Local Government
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
兵庫県立尼崎病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Measurement>
We will measure ultrasonographic optic nerve sheath diameter during first-time dialysis at 2 hours and 3 hours later.
<Primary Outcome>
Sensitivity, specificity of ultrasonographic optic nerve sheath diameter of patients undergoing first-time dialysis for the detection of dialysis disequilibrium syndrome will be calculated.
Receiver operator characteristic curve will be constructed to determine the optimal ultrasonographic optic nerve sheath diameter cut-off point to detect dialysis disequilibrium syndrome in patients undergoing first-time dialysis.
Management information
Registered date
| 2014 | Year | 12 | Month | 14 | Day |
Last modified on
| 2017 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017965
