JPRN-jRCTs051230072招募中3 期
For postoperative body fluid management and postoperative complication prevention Torbaptan's effectiveness
Esaki Jiro0 个研究点目标入组 200 人开始时间: 2023年7月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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