Obesity and Goal-directed Intraoperative Fluid Therapy

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Goal directed fluid therapy

• Registration Number: NCT01052519
• Lead Sponsor: Medical University of Vienna

Brief Summary

The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI\> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery.

Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management.

Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.

Detailed Description

Hemodynamic stability and normovolemia are critical determinants of tissue perfusion and oxygenation. Adequate tissue oxygenation is essential to maintain normal physiologic functions and to reduce complications, such as wound infections.

Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement.

It remains unknown how to hydrate obese surgical patients best. The most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Non-obese (BMI≤ 30kg/m2) and obese patients (BMI > 30 kg/m2)
• undergoing laparoscopic elective fundoplication or elective bariatric surgery

Exclusion Criteria

• decompensate heart failure
• documented coronary artery disease
• renal insufficiency
• severe chronic obstructive pulmonary disease
• symptoms of infection or sepsis
• esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-obese goal directed	Goal directed fluid therapy	-
obese goal-directed	Goal directed fluid therapy	-

Primary Outcome Measures

Name	Time	Method
Subcutaneous tissue oxygenation	intraoperative and 2 postoperative hours

Trial Locations

Locations (1)

Department of Anesthesiology, Medical University of Vienna; 🇦🇹 Vienna, Austria