UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000014197