For postoperative body fluid management and postoperative complication prevention Torbaptan's effectiveness

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051230072

Enrollment

200

Registered

2023-07-20

Start date

2023-10-11

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 receiving Open Heart Surgery

Interventions

Usual treatment group) Azosemide tablet + loop diuretic (physician's choice) study drug administration group) Azosemide tablets + tolvaptan injection

Tolvaptan Sodium Phosphate injection , Azosemid , loop diuretic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients planning to perform open heart surgery under a heart-lung machine 2) Patients who are aged 20 or older when acquiring consent 3) Patients who have obtained document consent with their own freedom after fully understood participation in this research

Exclusion criteria

Exclusion criteria: 1)Patients who underwent emergency surgery 2)Patients with a history of hypersensitivity to tolvaptan components or similar compounds (such as mozavaptan hydrochloride) 3)Patients receiving desmopressin acetate hydrate (nocturia due to nocturia in men) 4)Patients with a history of hypersensitivity to sulfonamide derivatives 5)Patients with heart failure and markedly decreased EF (EF148 mEq/L) before tolvaptan administration 13)Patients with hyperkalemia (K>5.3 mEq/L) before tolvaptan administration 14)Patients who are pregnant or may be pregnant 15)Patients who are participating in or planning to participate in other clinical trials (intervention stu dies) or clinical trials 16)Patients who are judged by the investigator (subinvestigator) to be inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
Cumulative urine volume 1-2 days after surgery	—

Secondary

Measure	Time frame
Presence or absence of postoperative complications -electrolyte abnormality -atrial fibrillation -acute renal failure -postoperative death Time until postoperative complications weight change -Weight loss on the 1st and 2nd days after surgery -Days to return to preoperative body weight Change of urine volume Daily urine volume on the 2nd, 3rd and 4th days after surgery Drug doses on postoperative day 4 and until hospital discharge (postoperative day 5-14 or discharge, whichever comes first) -Torvaptane -Catecholamine -Other diuretics -Basic infusion Artificial respiration management time Days of ICU stay All hospitalization period	—

Measure

Time frame

Presence or absence of postoperative complications -electrolyte abnormality -atrial fibrillation -acute renal failure -postoperative death Time until postoperative complications weight change -Weight loss on the 1st and 2nd days after surgery -Days to return to preoperative body weight Change of urine volume Daily urine volume on the 2nd, 3rd and 4th days after surgery Drug doses on postoperative day 4 and until hospital discharge (postoperative day 5-14 or discharge, whichever comes first) -Torvaptane -Catecholamine -Other diuretics -Basic infusion Artificial respiration management time Days of ICU stay All hospitalization period

—

Contacts

Public ContactAya Ako

Kobe City Medical Center General Hospital

aya_ako@kcho.jp+81-78-302-4321

Outcome results

None listed

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