Obesity and Goal-directed Intraoperative Fluid Therapy

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01052519
Collaborator
(none)
90
1
3
53
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Goal directed fluid therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: obese control

Active Comparator: obese goal-directed

Other: Goal directed fluid therapy
Fluid will be administered to reach maximal stroke volume during the intraoperative period.

Active Comparator: non-obese goal directed

Other: Goal directed fluid therapy
Fluid will be administered to reach maximal stroke volume during the intraoperative period.

Outcome Measures

Primary Outcome Measures

  1. Subcutaneous tissue oxygenation [intraoperative and 2 postoperative hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology, Medical University of Vienna Vienna Austria A-1070

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Barbara Kabon, MD, MUW

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Barbara Kabon, PD. MD., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01052519
Other Study ID Numbers:
  • 708/2009, local IRB
First Posted:
Jan 20, 2010
Last Update Posted:
Nov 19, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Barbara Kabon, PD. MD., Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2014