UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039193
Receipt number R000044697
Scientific Title Cerebral oxygenation in hemodialysis patients-comparison among different spectroscopes
Date of disclosure of the study information 2020/02/01
Last modified on 2021/01/19 15:39:35

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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 or person

Institute

Hokkaido University Hospital
Anesthesiology

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name