NCT02864355终止不适用
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Number of Participants With Cardiopulmonary Complications
研究概览
简要总结
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Patients undergoing primary resection of esophageal cancer and resultant esophagectomy.
排除标准
- •Patients < 55kg or > 140 kg, based on literature regarding accuracy of FloTrac.
- •Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation).
- •Patients with diagnosed NYHA class III-IV failure or documented EF < 30%
- •Patients who are unable/unwilling to consent for study procedures
结局指标
主要结局
Number of Participants With Cardiopulmonary Complications
时间窗: 7 days
Any documented cardiopulmonary complications present upon chart review.
次要结局
- Hospital Length of Stay(30 days)
- Anastomotic Leak Diagnosed Via Radiograph(7 days)
- Number of Participants With Renal Injury(7 days)
- Death(30 days)
- Length of Intensive Care Unit Stay(30 days)
研究者
研究点 (2)
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