A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery
Phase 4
- Conditions
- Patients received cardiothoracic surgery with congestive heart failure.
- Registration Number
- JPRN-UMIN000011172
- Lead Sponsor
- Osaka city university graduate school of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
Not provided
Exclusion Criteria
1 Patients with cardiogenic shock. 2 Patients with cardiac assist device. 3 Patients with disease, complication, and symptom, as follows. 1.Dehydration, 2.Adipsia, 3.Hypertrophic cardiomyopathy, 4.Hepatic coma, 5.Uncontrolled diabetes mellitus, 6.Anuria, 7.Disability of urinary excretion. 4 Amyloid myocarditis. 5 Patients with systolic blood pressure <90mmHg. 6 Patients with serum Na > 147 mEq/L or serum K > 5.5 mEq/L or T - bilirubin > 3.0 mg/dL. 7 Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 The days before returning to the preoperative weight 2 Nomarization ratio of the serum creatinine after cardiothoracic surgery
- Secondary Outcome Measures
Name Time Method 1. Body weight, cumulative urine volume, and volume of drinking water. 2. Incidence of the arrhythmia. 3. Congestive signs. 4. Thoracic X-ray, echocardiography. 5. Serum Na, K, osmolality, rennin activity. 6. Urinary Na, K, osmolality, 7. Usage of diuretics in hospitalization period. 8. The number of Re-hospitalization times and total days in hospitalization period after surgery.