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
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
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
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
