Congestive heart failure patients
Conditions
Interventions
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.
Non-tolvaptan arm: Inject furosemide 10 mg or more. Furosemide administratio
Sponsors
Division of Cardiovascular Medicine , Department of Internal Medicine,Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU sojourn time | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactToshiro Shinke
Department of Internal Medicine, Kobe University Graduate School of Medicine Division of Cardiovascular Medicine
Outcome results
None listed