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

JRCT ID: jRCTs051230072

Registered date:20/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients receiving Open Heart Surgery
• Date of first enrollment: 11/10/2023
• Target sample size: 200
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Cumulative urine volume 1-2 days after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 (EF<30%)
6)Patients with chronic renal dysfunction on dialysis
7)Patients with liver cirrhosis
8)Patients who underwent thoracoabdominal aortic replacement or heart-beating coronary artery bypass surgery alone
9)Patients who are already using tolvaptan including oral medicines and injections at
the time of informed consent
10)Patients who need to use carperitide at the time of informed consent or throughout the study period
11)Patients who cannot feel thirst or have difficulty in taking fluids
12)Patients with hypernatremia (Na>148 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

Related Information

• Primary Sponsor: Esaki Jiro
• Secondary Sponsor: Matsuda Yasuhiro