Obesity and Goal-directed Intraoperative Fluid Therapy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Medical University of Vienna.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01052519

First received: January 19, 2010

Last updated: July 22, 2010

Last verified: July 2010

History of Changes

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:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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:	December 2011
Estimated Primary Completion Date:	December 2011 (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

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:

Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80.

Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9.

Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6.

Responsible Party:	Barbara Kabon, 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:	July 22, 2010
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 June 18, 2013

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