UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optic nerve sheath diameter for the detection of dialysis disequilibrium syndrome
Title of the study (Brief title)	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	HIraku Tsujimoto
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department of Nephrology
Address	1-1, Higashidaimotsu-cho 1-chome, Amagasaki, Hyogo, Japan
TEL	06-6482-1521
Email	hira_to_ber3598@yahoo.co.jp

Public contact
Name of contact person	HIraku Tsujimoto
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department of Nephrology
Address	1-1, Higashidaimotsu-cho 1-chome, Amagasaki, Hyogo, Japan
TEL	06-6482-1521
Homepage URL
Email	hira_to_ber3598@yahoo.co.jp

Sponsor
Institute	Department of Nephrology, Hyogo Prefectural Amagasaki Hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017965