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临床试验/NCT03788070
NCT03788070终止不适用

Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2019年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
188
试验地点
1
主要终点
Prevalence of Dehydration at Induction of Anesthesia

研究概览

简要总结

The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. The hypothesis is that preoperative dehydration leads to more postoperative complications.

详细描述

The information about the impact of preoperative dehydration on postoperative outcome is conflicting. One of the reported difficulties of the studies in this field is to get adequate power for statistical significance. The incidence of preoperative dehydration in different surgical populations has been reported in about one third of patients. The prevalence in the urologic population is not known.

This is a monocentric observational study with no study intervention. The goal is to consecutively include all patients undergoing major urologic surgery during 365 days who meet the inclusion criteria to assess the prevalence of preoperative dehydration in elective major abdominal urologic surgery when the standard operation procedures of the University Hospital Bern are applied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • >18 years old
  • Major elective urologic surgery i. Prostate surgery ii. Bladder surgery iii. Kidney surgery iv. Various laparotomies / laparoscopies (e.g. retroperitoneal lymphadenectomy)
  • Standard procedure planned
  • Standard perioperative management planned
  • Informed consent

排除标准

  • Preoperative iv-fluids
  • Pregnancy (which is a contraindication to this type of surgery per se)
  • Inability to give informed consent (e.g. severe psychiatric disorder, dementia)
  • Inability to complete the Quality of Recovery (QoR) questionnaire
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

结局指标

主要结局

Prevalence of Dehydration at Induction of Anesthesia

时间窗: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery

Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.

次要结局

  • Postoperative Nausea and Vomiting (PONV)(6 hours, 24 hours and 48 hours postoperatively)
  • Gastrointestinal function (flatus/defecation) postoperatively(24 hours and 48 hours postoperatively)
  • Complications within hospitalization(within hospital stay, expected to be within 2 weeks postoperatively)
  • Quality of recovery(24 hours postoperatively)
  • Renal function postoperatively(6 hours, 24 hours and 48 hours postoperatively)
  • Fluid balance(within 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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