UMIN-CTR Clinical Trial

Basic information
Public title	Cerebral oxygenation in hemodialysis patients-comparison among different spectroscopes
Acronym	Hemodialysis patients and cerebral oxygenation
Scientific Title	Cerebral oxygenation in hemodialysis patients-comparison among different spectroscopes
Scientific Title:Acronym	Hemodialysis patients and cerebral oxygenation
Region	Japan

Condition
Condition	Patients scheduled to have hemodialysis
Classification by specialty	Medicine in general Nephrology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure the cerebral oxygenation by using three kinds of near-infrared spectroscopes with different principles at pre- and post- hemodialysis and to compare the values.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference in cerebral oxygenation among different spectroscopes in hemodialysis patients
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ASA 3, who have hemodialysis in the of Hokkaido University Hospital
Key exclusion criteria	1 Patienst with intracranial disease 2 Patients with cardiac failure above NYHA 3
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Morimoto
Organization	Hokkaido University Hospital
Division name	Anesthesiology
Zip code	0608648
Address	N14 W5, Kita-ku, Sapporo
TEL	011-716-1161
Email	morim2@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Morimoto
Organization	Hokkaido University Hospital
Division name	Anesthesiology
Zip code	0608648
Address	N14 W5, Kita-ku, Sapporo
TEL	011-716-1161
Homepage URL
Email	morim2@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital Anesthesiology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Hospital Division of Clinical Research Administration
Address	N14 W4, Kita-ku, Sapporo
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 01 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	0
Results	The study was cancelled before patient enrollment due to coronavirus pandemic.
Results date posted	2021 Year 01 Month 19 Day
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	2019 Year 12 Month 24 Day
Date of IRB	2020 Year 01 Month 10 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study Study period: until 2017.7.25 Patients who have hemodialysis in the Hokkaido University Hospital and meet the criteria Observational items: Background, laboratory data, vital signs during hemodialysis, cerebral hemoglobin concentration

Management information
Registered date	2020 Year 01 Month 18 Day
Last modified on	2021 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044697