A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management
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
- 否
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
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
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
Barbara Kabon
MD
Medical University of Vienna
