A study on the safety and effectiveness of tolvaptan for patients with fluid retention after valvular surgery

A study on the safety and effectiveness of tolvaptan for patients with fluid retention after valvular surgery - Study of tolvaptan for fluid retention after valve surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009957

Enrollment

100

Registered

2013-02-05

Start date

2013-02-01

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 cardiac surgery for cardiac valvular disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient who plans a valve surgery (AV, MV, TV, PV) 2.Patients who takes existing diuretic 3.The patient is willing to participate in the study

Exclusion criteria

Exclusion criteria: 1.Patients with hypersensitivity to study drug 2.Anuric patients 3.Patients with hypernatremia 4.Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant 5.Malignant tumor 6.Patients with serious hepatic disorder or Serious Renal failure 7.Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Design outcomes

Primary

Measure	Time frame
The days before returning to the preoperative weight	—

Secondary

Measure	Time frame
1.A cumulative urine volume for 48 hours 2.Echocardiography on the seven days 3.Change of Congestive Signs and correction of potassium 4.Change of serum marker (Cr, BUN, Na, K) 5.Usage of diuretics 6.Postoperative length of stay 7.Onset of cardiovascular event 8.Onset of serious adverse event	—

Countries

Japan

Contacts

Public ContactHiroyuki Nishi

Osaka University Graduate School of Medicine Department of Cardiovascular Surgery

06-6879-3154

Outcome results