A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
The purpose of this study is to find out if giving a medicine called furosemide, which is a diuretic or water pill, after colon surgery will safely shorten the patient's length of hospital stay.
详细描述
This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Furosemide + Enhanced Recovery after Surgery (ERAS)
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
干预措施: Celecoxib (Drug)
Furosemide + Enhanced Recovery after Surgery (ERAS)
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
干预措施: Furosemide (Drug)
Furosemide + Enhanced Recovery after Surgery (ERAS)
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
干预措施: Gabapentin (Drug)
Enhanced Recovery after Surgery (ERAS)
ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
干预措施: Celecoxib (Drug)
Enhanced Recovery after Surgery (ERAS)
ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Length of Hospital Stay
时间窗: Up to 7 days
Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.
次要结局
- Time to Stool Output(Up to 4 days)
- Number of Participants Requiring Nasogastric Tube Placement(Up to 7 days)
- Number of Participants Readmitted to Mayo Clinic Within 30-days(Within 30 days of release from hospital)
- Number of Participants With Acute Kidney Injury(Up to 7 days)
- Number of Participants With Hypokalemia(Up to 7 days)
研究者
Ilya M. Danelich, Pharm.D., R.Ph.
PI
Mayo Clinic
