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Obesity and Goal-directed Intraoperative Fluid Therapy

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Medical University of Vienna

Status

Completed

Conditions

Obesity

Treatments

Other: Goal directed fluid therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01052519
708/2009, local IRB

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

obese control
No Intervention group
obese goal-directed
Active Comparator group
Treatment:
Other: Goal directed fluid therapy
non-obese goal directed
Active Comparator group
Treatment:
Other: Goal directed fluid therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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