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Completed

NCT Number: NCT01052519

Obesity and Goal-directed Intraoperative Fluid Therapy

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Medical University of Vienna

Vienna, A-1070, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Goal directed fluid therapy

Other

Fluid will be administered to reach maximal stroke volume during the intraoperative period.

Primary outcomes

  1. Subcutaneous tissue oxygenation

    Time frame: intraoperative and 2 postoperative hours

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2010
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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