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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012272
Receipt No. R000014197
Scientific Title Change of central venous oxygen saturation (ScvO2) before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Date of disclosure of the study information 2013/11/12
Last modified on 2019/05/17

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Basic information
Public title Change of central venous oxygen saturation (ScvO2) before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Acronym Change of central venous oxygen saturation (ScvO2) before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Scientific Title Change of central venous oxygen saturation (ScvO2) before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Scientific Title:Acronym Change of central venous oxygen saturation (ScvO2) before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Region
Japan

Condition
Condition kidney disease
Classification by specialty
Nephrology Infectious disease Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the change of ScvO2 before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Basic objectives2 Others
Basic objectives -Others Physiology: To evaluate the change of ScvO2 before and after the arterio-venous fistula creation in non-septic patients with kidney failure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) The change of ScvO2 before and after the treatment
2) Blood flow in arterio-venous fistula
3) Cardiac output
Key secondary outcomes 1) Observation of the changes in ScvO2 until the first use of the arterio-venous fistula
2) Observation of the change in the blood flow of arterio-venous fistula until the first use of the arterio-venous fistula

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 1) The patients with chronic renal failure who undergo hemodialysis using double lumen catheter inserted at the internal jugular vein
2) The patients with stable health condition except for renal failure
3) Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria 1) The patients undergoing hemodialysis using double lumen catheter placed in femoral vein
2) The patients who received a blood transfusion between the measurements of ScvO2
3) The patients who had a major change in dry weight between the measurements of ScvO2
4) The patients receiving oxygen therapy
5) The patients whose flow of arterio-venous shunt is too small to perform hemodialysis
6) The patients who has other diseases affecting the blood oxygenation level
7) The patients who were judged inappropriate by the principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terumasa HAYASHI
Organization Osaka General Medical Center
Division name Department of Kidney Disease and Hypertension
Zip code
Address 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Email kenkyusien@gh.opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Terumasa HAYASHI
Organization Osaka General Medical Center
Division name Nephrology/Hypertension
Zip code
Address 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Homepage URL
Email kenkyusien@gh.opho.jp

Sponsor
Institute Osaka General Medical Center
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
Address
Tel
Email

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
2013 Year 11 Month 12 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
2013 Year 06 Month 11 Day
Date of IRB
2013 Year 06 Month 11 Day
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:Prospective observational study
Sampling:All patients who match the eligibility are entried.
No control group
Comparative study in individual patients

Management information
Registered date
2013 Year 11 Month 12 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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