A Phase 4 interventional study of Lactated Ringer's Solution and Hydroxyethylstarch 6% 130/0.4 in Fluid Overload and Postoperative Complications, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
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.
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] .
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 1,109 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
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.
Drug: Lactated Ringer's Solution
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.
Drug: Hydroxyethylstarch 6% 130/0.4
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.
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.
combined perioperative morbidity
Time frame: 30 days after surgery
Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,
Time frame: 30 days after surgery
Coagulation (ROTEM)
in a subgroup of 50 patients undergoing hepatic resection ROTEM measurements will be performed intraoperatively, postoperatively and on the first postoperative morning and compared between the groups.
Time frame: intraop, postop day1
Inflammatory response attenuation by HES 130/0.4
In a subgroups of 120 patients the postoperative immune function will be evaluated and compared between crystalloids and colloids. The immunological parameters include: IL6, IL-8, IL-10, Procalcitonin, lipopolysaccharide-binding protein, HLA-DR Expression, CRP C-reactive protein, leucocytes, TNF alpha Blood samples will be collected immediately before surgery (T0) for baseline measurement, immediately after surgery finish (T1), and on postoperative day one, two and four (T2, T3 and T4).
Time frame: 4 postoperative days
Body Composition Monitor Measurement (BCM)
In a subgroup of 100 patients overhydration will be evaluated pre- and immediately postoperatively with a body composition monitor (BCM), a whole-body bioimpedance spectroscopy device manufactured and distributed by Fresenius Medical Care, Germany. Measurements will be compared betwwen the groups
Time frame: pre and postoperatively
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna