Obesity and Goal-directed Intraoperative Fluid Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Barbara Kabon, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01052519
First received: January 19, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Obesity
Other: Goal directed fluid therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Subcutaneous tissue oxygenation [ Time Frame: intraoperative and 2 postoperative hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052519

Contacts
Contact: Barbara Kabon, MD 0043140400 ext 4107 barbara.kabon@meduniwien.ac.at

Locations
Austria
Department of Anesthesiology, Medical University of Vienna Recruiting
Vienna, Austria, A-1070
Contact: Barbara Kabon, MD    0043140400 ext 4128    barbara.kabon@meduniwien.ac.at   
Principal Investigator: Barbara Kabon, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Barbara Kabon, MD MUW
  More Information

Publications:
Responsible Party: Barbara Kabon, PD. MD., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01052519     History of Changes
Other Study ID Numbers: 708/2009, local IRB
Study First Received: January 19, 2010
Last Updated: April 1, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Obesity
Esophageal Doppler monitoring
tissue oxygen tension

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014