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临床试验/NCT02351934
NCT02351934已完成4 期

A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

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

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)

Experimental

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)

Experimental

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)

Experimental

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)

Active Comparator

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)

Active Comparator

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilya M. Danelich, Pharm.D., R.Ph.

PI

Mayo Clinic

研究点 (1)

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