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临床试验/NCT01563991
NCT01563991已完成不适用

Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Morbidity

研究概览

简要总结

Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.

详细描述

The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.

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

  • Patients 18 years or older
  • ASA I-III
  • Ability to provide informed consent
  • Creatinine less than or equal to 1.3 mg/mL)

排除标准

  • Patients younger than 18 years old
  • ASA IV or higher
  • Urgent or emergent surgery
  • Mental disease or addictive disorders impairing ability to provide informed consent
  • Renal insufficiency (Cr greater than 1.3 mg/mL)
  • Significant language barriers
  • Cirrhosis causing ascites
  • NYHA III or IV, EF less than 25%
  • Use of intraoperative epidural anesthesia
  • Uncontrolled diabetes
  • Uncontrolled hypertension in the opinion of the enrolling surgeon
  • ETOH consumption greater than 35 drinks weekly
  • Cachexia or absolute neutrophil count of less than 1,200/mm3
  • Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3

结局指标

主要结局

Morbidity

时间窗: 5-7 days

Reduction in post-operative complications at the time of hospital discharge after the surgical episode

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Stocchi

MD

The Cleveland Clinic

研究点 (2)

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