A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management
Overview
- Phase
- Phase 4
- Intervention
- Lactated Ringer's Solution
- Conditions
- Fluid Overload
- Sponsor
- Medical University of Vienna
- Enrollment
- 1109
- Locations
- 1
- Primary Endpoint
- combined perioperative morbidity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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 \[Bennett-Guerrero 1999\] .
Investigators
Barbara Kabon
MD
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Lactated Ringer's Solution
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.
Intervention: Hydroxyethylstarch 6% 130/0.4
Outcomes
Primary Outcomes
combined perioperative morbidity
Time Frame: 30 days after surgery
Secondary Outcomes
- Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,(30 days after surgery)