UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028145
Receipt number R000032183
Scientific Title Effect of dose, interval and rate of bolus dialysate infusion for hypotension in intermittent infusion hemodiafiltration
Date of disclosure of the study information 2017/07/10
Last modified on 2020/01/09 11:52:22

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Basic information

Public title

Effect of dose, interval and rate of bolus dialysate infusion for hypotension in intermittent infusion hemodiafiltration

Acronym

Effect of dose, interval and rate of bolus dialysate infusion for hypotension in intermittent infusion hemodiafiltration

Scientific Title

Effect of dose, interval and rate of bolus dialysate infusion for hypotension in intermittent infusion hemodiafiltration

Scientific Title:Acronym

Effect of dose, interval and rate of bolus dialysate infusion for hypotension in intermittent infusion hemodiafiltration

Region

Japan


Condition

Condition

Chronic kidney disease with hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate relation of dose, interval and rate of bolus dialysate infusion for hypotension in intermittent infusion hemodiafiltration

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of blood pressure and heart rate

Key secondary outcomes

Intervention frequency for hypotension
KT/V


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Dose/interval, rate
200ml/30min, 100ml/min
2 weeks

Interventions/Control_2

Dose/interval, rate
200ml/30min, 150ml/min
2 weeks

Interventions/Control_3

Dose/interval, rate
100ml/30min, 150ml/min
2 weeks

Interventions/Control_4

Dose/interval, rate
100ml/15min, 150ml/min
2 weeks

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) who received hemodialysis in our clinic, (2) whose medical decisions were made at our hospitals, and (3) who were over 20 years of age.

Key exclusion criteria

They had active inflammatory disease or malignancy

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Otsubo

Organization

Tohto Sangenjaya Clinic

Division name

Department of Blood Purification

Zip code

154-0004

Address

2-13-2 Taishido, Setagaya-ku, Tokyo, Japan

TEL

03-6805-3750

Email

sotsubo@hb.tp1.jp


Public contact

Name of contact person

1st name Shigeru
Middle name
Last name Otsubo

Organization

Tohto Sangenjaya Clinic

Division name

Department of Blood Purification

Zip code

154-0004

Address

2-13-2 Taishido, Setagaya-ku, Tokyo, Japan

TEL

03-6805-3750

Homepage URL


Email

sotsubo@hb.tp1.jp


Sponsor or person

Institute

Tohto Sangenjaya Clinic

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

Sangenjaya Hospital

Address

1-21-5 Sangenjaya Setagaya-Ku Tokyo

Tel

03-3410-7321

Email

sangenjaya-hp@hotmail.co.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



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 10 Day


Related information

URL releasing protocol

None

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/?term=Relationship+between+Dose+of+Bolus+Dialysate+Infusion+and+

Number of participants that the trial has enrolled

77

Results

Among patients with a body weight of 52 kg or more, the blood pressure was more stable when a bolus fluid volume of 200 mL was used, compared with a volume of 100 mL. Among patients with a body weight of less than 52 kg, however, the significance of the difference in bolus fluid volumes disappeared.

Results date posted

2020 Year 01 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

77 patients underwent Intermittent Infusion Hemodiafiltration

Participant flow

). Two bolus infusion volumes were compared: 100 mL and 200 mL. Each observation period was 2 weeks.
None dropped

Adverse events

None

Outcome measures

The systolic blood pressure (SBP) was estimated at the start, at the highest SBP, at the lowest SBP, and at the end of hemodialysis therapy.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 07 Month 10 Day

Date of IRB

2017 Year 06 Month 30 Day

Anticipated trial start date

2017 Year 07 Month 10 Day

Last follow-up date

2017 Year 11 Month 10 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 08 Day

Last modified on

2020 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name