NCT00517127

Crystalloids Versus Colloids During Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,109 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 \[Bennett-Guerrero 1999\] .

Conditions

• Fluid Overload
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Lactated Ringer's Solution	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	Hydroxyethylstarch 6% 130/0.4	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2007-08-16
• Last updated: 2018-01-10

Locations

1 site across 1 country: Austria