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Obesity and Goal-directed Intraoperative Fluid Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbara Kabon, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01052519
First received: January 19, 2010
Last updated: November 18, 2014
Last verified: November 2014

January 19, 2010
November 18, 2014
January 2010
June 2014   (final data collection date for primary outcome measure)
Subcutaneous tissue oxygenation [ Time Frame: intraoperative and 2 postoperative hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01052519 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Obesity and Goal-directed Intraoperative Fluid Therapy
Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Obesity
Other: Goal directed fluid therapy
Fluid will be administered to reach maximal stroke volume during the intraoperative period.
  • No Intervention: obese control
  • Active Comparator: obese goal-directed
    Intervention: Other: Goal directed fluid therapy
  • Active Comparator: non-obese goal directed
    Intervention: Other: Goal directed fluid therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2014
June 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01052519
708/2009, local IRB
No
Barbara Kabon, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Barbara Kabon, MD MUW
Medical University of Vienna
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP