UMIN-CTR Clinical Trial

Public title

Evaluation of ultrafiltration control using blood volume monitor during hemodialysis

Acronym

UF control using BVM during HD

Scientific Title

Evaluation of ultrafiltration control using blood volume monitor during hemodialysis

Scientific Title:Acronym

UF control using BVM during HD

Region

Japan

Condition

maintenance hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We compare the occurrence of intradialytic hypotension between hemodialysis (HD) therapies based on a ultrafiltration control of blood volume (BV-UFC) using blood volume monitor (BVM) and those with constant ultrafiltration in this study, and aims to confirm the safety of fluid-balance management during HD under the use of BV-UFC as well as the safety of conventional HD therapy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Occurrence of intradialytic hypotensin

Key secondary outcomes

Management necessity to intradialytic hypotension
Change of vlood volume after HD
Change of blood pressure during HD
Achievement of targeted fluid-management after HD

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Evaluation period: 8 weeks
Methods:
In each included HD patient, conventional HD and HD under the use of BV-UFC by BVM are performed, which are also crossed at 1st and 2nd HD day in each week, for 8 weeks. 3rd HD therapy are excluded in the analysis of this study.

Study schedule (weekly)

(period) 1st HD 2nd 3rd
1st week conventional BV-UFC conventional
2nd week BV-UFC conventional BV-UFC
3rd week conventional BV-UFC conventional
4th week BV-UFC conventional BV-UFC
...
8th week BV-UFC conventional BV-UFC

conventional HD: HD therapy with constant ultrafiltration.
BV-UFC: HD therapy with BV-UFC using BVM

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

patients undergoing HD.
HD duration is more than 3 months with stable condition.
Patients with hemoconcentration after HD compared with before HD.
Serum albumin concentration is more than 3.0 g/dL.
HD session is 4 hour.

Key exclusion criteria

below age of 20 years.
patients who are impossible to perform self-judgement.
patients with body weight gain less than 1.0 kg.
patients who take anti-hypertensive or anti-hypotensive medicine from one hour before HD to HD procedure.
patients with frequent postural changes during HD.
patients with a suspicion of vascular access resirculation.
patients with old myocardial infarction.
patients with angina pectoris.
patients with severe cardiovascular diseases.
patients with pregnancy or a possibility of pregnancy.
patients who are thought inadequate by doctor.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Susumu Ookawara

Organization

Saitama Medical Center, Jichi Medical University

Division name

First department of Integrated Medicine

Zip code

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama

TEL

048-647-2111

Email

ookawaras@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Susumu Ookawara

Organization

Saitama Medical Center, Jichi Medical University

Division name

First department of Integrated Medicine

Zip code

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama

TEL

048-647-2111

Homepage URL

Email

ookawaras@jichi.ac.jp

Institute

Division of Nephrology, First Department of Integrated Medicine, Jichi Medical University

Institute

Department

Personal name

Organization

Nikiso Corporation, Tokyo, Japan

Organization

Division

Category of Funding Organization

Profit organization

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

2016

Year

12

Month

01

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

2016

Year

09

Month

28

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

01

Day

Last follow-up date

2017

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

2017

Year

10

Month

01

Day

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

01

Day

Last modified on

2017

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028372