UMIN-CTR Clinical Trial

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

kidney disease

Classification by specialty

Nephrology	Infectious disease	Emergency medicine
Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka General Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

Registered date

2013

Year

11

Month

12

Day

Last modified on

2019

Year

05

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014197