Crystalloids Versus Colloids During Surgery

Phase 4

Completed

• Conditions: Fluid Overload; Postoperative Complications
• Interventions: Drug: Hydroxyethylstarch 6% 130/0.4; Drug: Lactated Ringer's Solution

• Registration Number: NCT00517127
• Lead Sponsor: Medical University of Vienna

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 \[Bennett-Guerrero 1999\] .

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	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.
1	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.

Primary Outcome Measures

Name	Time	Method
combined perioperative morbidity	30 days after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria