For postoperative body fluid management and postoperative complication prevention Torbaptan's effectiveness
- Conditions
- Patients receiving Open Heart Surgery
- Registration Number
- JPRN-jRCTs051230072
- Lead Sponsor
- Esaki Jiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative urine volume 1-2 days after surgery
- Secondary Outcome Measures
Name Time Method Presence or absence of postoperative complications<br> -electrolyte abnormality<br> -atrial fibrillation<br> -acute renal failure<br> -postoperative death <br>Time until postoperative complications weight change<br> -Weight loss on the 1st and 2nd days after surgery<br> -Days to return to preoperative body weight<br>Change of urine volume<br>Daily urine volume on the 2nd, 3rd and 4th days after surgery<br>Drug doses on postoperative day 4 and until hospital discharge (postoperative day 5-14 or discharge, whichever comes first)<br> -Torvaptane<br> -Catecholamine<br> -Other diuretics<br> -Basic infusion<br>Artificial respiration management time<br>Days of ICU stay<br>All hospitalization period