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临床试验/NCT01399814
NCT01399814已完成3 期

Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer

Nanjing PLA General Hospital0 个研究点目标入组 179 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
179
主要终点
clinical perioperative complications

研究概览

简要总结

The purpose of this study is to find out whether perioperative fluid restriction influence on postoperative immunological function. And discuss the probable mechanism that fluid restriction regime effect on clinical data.

详细描述

Perioperative fluid administration is a common therapy in clinical practice, and recent regime has a history about 50 years. Recently, clinicians found that traditional regime had some disadvantages, for example, pulmonary edema, increased cardiac load, increased body weight. And thus, perioperative fluid restriction regimen has been suggested and proved could reduce cardiopulmonary complications and mortality rates after major elective gastrointestinal surgery.

Patients were divided into two groups randomly and underwent restricted fluid regimen or traditional fluid regimen. We determined the complications and immunological function in two groups, and analyzed the relationship between complications and immunological changes. Based on this we decide the probable mechanism that perioperative fluid restriction effects on complications.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients(age≧65y) who was admitted for gastrointestinal cancer surgery were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)

排除标准

  • lactation
  • mental disorders
  • language problems
  • smoking within two weeks
  • diabetes mellitus
  • renal insufficiency
  • disseminated cancer
  • secondary cancers
  • inflammatory bowel disease, or diseases hindering epidural analgesia

结局指标

主要结局

clinical perioperative complications

时间窗: 30 days after surgery

次要结局

  • death(30 days after surgery)
  • adverse effects(30 days after surgery)

研究者

发起方
Nanjing PLA General Hospital
申办方类型
Other

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