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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007037
Receipt No. 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

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

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
URL(English) https://upload.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


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