UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007037
Receipt number R000008298
Scientific Title QUalification of Efficacy in the study of intENsive care with Tolvaptan
Date of disclosure of the study information 2012/02/01
Last modified on 2013/12/18 11:08:34

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Basic information

Public title

QUalification of Efficacy in the study of intENsive care with Tolvaptan

Acronym

QUEEN trial

Scientific Title

QUalification of Efficacy in the study of intENsive care with Tolvaptan

Scientific Title:Acronym

QUEEN trial

Region

Japan


Condition

Condition

Congestive heart failure patients

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We intend for an inpatient of ICU in therapeutic purpose of congestive heart failure and review the effectiveness and safety by weighing ICU sojourn time against a group to treat with existing loop diuretic with a group using tolvaptan together to loop diure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

ICU sojourn time

Key secondary outcomes

1.The amount of accumulation urine of 72 hours
2.Change in body weight
3.Change in Congestive Signs
(Lower limb edema,any edema,Jugular Venous.Distention,Hepatomegaly,Crackles lung,Third heart sound)
4.Chest X ray (cardio-thoracic ratio,Pulmonary Congestion)
5.Change in Plasma BNP
6.Change in Serum Na+,Change in Serum K+,Change in serum osmolality
7.Change in BUN,Change in Cr,Change in eGFR
8.New York heart associationcardiac functional classification
9.Hourly urine volume(start to 48h)
10.Daily urine volume
11.Outcome at the time of hospital discharge
(Remission,Changing hospital,Death)
12.Outcome at the time after 1month
13.Quantitative evaluation of pleural effusion
14..Cardiac output
15.Echocardiography
16.SPO2
17.blood gas analysis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tolvaptan arm:
After injecting furosemide 10 mg or more, administer tolvaptan orally (starting dose: 3.5 mg/day or 7.5 mg/day; maximum dose: 15 mg/day) during the stay in the intensive care unit. Furosemide injection thereafter is not specified.

Interventions/Control_2

Non-tolvaptan arm:
Inject furosemide 10 mg or more. Furosemide administration thereafter is not specified.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

1.Congestive heart failure patients who are in ICU.
2.Patients fall under clinical scenario 1, 2, 5., and administration of diuretics are considered.
3.Age: 20 years or older to 90 years less at the time of the consents.
4.The patient whom the person himself has received explanation of this clinical trial and understands the contents, and person himself or his surrogate signs in consent form

Key exclusion criteria

1.Acute myocardial infarction
2.Patients with circulatory assist device
3.Severe hypotension or cardiogenic shock
4.Patients are considered undesirable rapid decrease in blood flow circulation
5.Patients with right heart ventricular infarction
6.Activ form of myocarditis
7.Patients with dehydration
8.Total bilirubin>3.0mg/dL
9.Serum K>5.5mEq/L
10.Serum K>5.5mEq/L
11.Patietns with hypersensitivity to study drug
12.Anuric patients
13.Insensitivity to the thirst or difficult for the water intake
14.Hypernatremia (serum Na>147mEq/L)
15.Pregnant woman, lactational woman, patients may be willing to be pregnant or are pregnant
16.In addition, patients were judged as inadequate by physician

Target sample size

54


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiro Shinke

Organization

Department of Internal Medicine, Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-5846

Email

shinke@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiro Shinke

Organization

Department of Internal Medicine, Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-5846

Homepage URL


Email

shinke@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Cardiovascular Medicine , Department of Internal Medicine,Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

神戸大学大学院医学研究科循環器内科(兵庫県)
神戸労災病院(兵庫県)
神戸市立医療センター中央市民病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 01 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

Preinitiation

Date of protocol fixation

2011 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 01 Month 08 Day

Last modified on

2013 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008298


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name