A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery

A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery - A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011172

Enrollment

210

Registered

2013-07-12

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients received cardiothoracic surgery with congestive heart failure.

Interventions

Conventional therapy group Tolvaptan low dose group Tolvaptan standard dose group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patient show body weight increase 1.5kg or more compared with preoperative weight in 2POD, with fluid retention after cardiothoracic surgery.. 2 In hospitalized patients. 3 The patient is willing to participate in the study.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
1 The days before returning to the preoperative weight 2 Nomarization ratio of the serum creatinine after cardiothoracic surgery	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYasuo Suehiro

Osaka City General Hospital Cardiovascular Surgery

m1111321@med.osaka-cu.ac.jp06-6929-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026