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临床试验/NCT00517127
NCT00517127已完成4 期

A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 1,109 人开始时间: 2006年9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
入组人数
1,109
试验地点
1
主要终点
combined perioperative morbidity

研究概览

简要总结

The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.

详细描述

For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently [Roberts 2004]. However, it has been suggested that both questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs [Boldt 2003].

Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair 1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005, Noblett 2006]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar 2003].

Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.

排除标准

  • Patients having severe cardiac or renal insufficiency
  • Patients with severe coronary artery disease
  • Patients with insulin-dependent diabetes mellitus
  • Patients with severe COPD
  • Patients with symptoms of infections or sepsis
  • Patients with allergy to hydroxyethylstarch.

研究组 & 干预措施

1

Active Comparator

Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.

干预措施: Lactated Ringer's Solution (Drug)

2

Active Comparator

Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.

干预措施: Hydroxyethylstarch 6% 130/0.4 (Drug)

结局指标

主要结局

combined perioperative morbidity

时间窗: 30 days after surgery

次要结局

  • Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,(30 days after surgery)

研究者

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

Barbara Kabon

MD

Medical University of Vienna

研究点 (1)

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