UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031762
Receipt number R000036262
Scientific Title Study of body fluid management in patients after cardiac surgery by preoperative administration of tolvaptan
Date of disclosure of the study information 2018/04/01
Last modified on 2020/06/01 10:27:21

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Basic information

Public title

Study of body fluid management in patients after cardiac surgery by preoperative administration of tolvaptan

Acronym

Study of body fluid management by preoperative administration of tolvaptan

Scientific Title

Study of body fluid management in patients after cardiac surgery by preoperative administration of tolvaptan

Scientific Title:Acronym

Study of body fluid management by preoperative administration of tolvaptan

Region

Japan


Condition

Condition

Cardiac disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Preoperative administration of tolvaptan facilitates postoperative fluid control.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The number of days until the peoperative body weight plus minus 1kg

Key secondary outcomes

AVP, renin, aldosterone, BUN, Cre, eGFR, Na, K, Alb, osmotic pressure
postoperative weight / urine volume, number of hospital days, time to withdrawal of the ventilator, number of thoracic punctures, postoperative atrial fibrillation, infection, death


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of tolvaptan

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.Person undergoing cardiac surgery
2.Those who have consent

Key exclusion criteria

1.Allergy of this drug
2.serious liver/renal dysfunction
3.Dialysis patients
4.Emergency surgery case
5.Those who have made a request for refusal in participating in this research
6.Others who judged that the research director is inappropriate as the research subject

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Keito
Middle name
Last name Suzuki

Organization

Nihon University School of Medicine

Division name

Cardiovascular Surgery

Zip code

173-8610

Address

30-1 Oyaguchi-kamimachi Itabashi-ku Tokyo, 173-8610, Japan

TEL

81-3-3972-8111

Email

suzuki.keito@nihon-u.ac.jp


Public contact

Name of contact person

1st name keito
Middle name
Last name Suzuki

Organization

Nihon University School of Medicine

Division name

Cardiovascular Surgery

Zip code

173-8610

Address

30-1 Oyaguchi-kamimachi Itabashi-ku Tokyo, 173-8610, Japan

TEL

81-3-3972-8111

Homepage URL


Email

suzuki.keito@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University School of Medicine

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

Itabashi Hospital Clinical Research Ethics Review Committee

Address

30-1 Oyaguchi-kamimachi Itabashi-ku Tokyo, 173-8610, Japan

Tel

81-3-3972-8111

Email

takei.masami@nihon-u.ac.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

2018 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Enrolling by invitation

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 03 Month 13 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2019 Year 07 Month 01 Day

Date of closure to data entry

2019 Year 07 Month 01 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 16 Day

Last modified on

2020 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036262


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name