NCT01052519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

4.4 years

First QC Date

January 19, 2010

Last Update Submit

November 18, 2014

Conditions

Obesity

Keywords

ObesityEsophageal Doppler monitoringtissue oxygen tension

Outcome Measures

Primary Outcomes (1)

  • Subcutaneous tissue oxygenation

    intraoperative and 2 postoperative hours

Study Arms (3)

obese control

NO INTERVENTION

obese goal-directed

ACTIVE COMPARATOR
Other: Goal directed fluid therapy

non-obese goal directed

ACTIVE COMPARATOR
Other: Goal directed fluid therapy

Interventions

Goal directed fluid therapyOTHER

Fluid will be administered to reach maximal stroke volume during the intraoperative period.

non-obese goal directedobese goal-directed

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-obese (BMI≤ 30kg/m2) and obese patients (BMI \> 30 kg/m2)
  • undergoing laparoscopic elective fundoplication or elective bariatric surgery

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Medical University of Vienna

Vienna, A-1070, Austria

Location

Related Publications (4)

  • 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. doi: 10.1097/00000542-200402000-00015.

    PMID: 14739800BACKGROUND

  • 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. doi: 10.1381/0960892054222867.

    PMID: 15978153BACKGROUND

  • 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. doi: 10.1097/00000542-200210000-00012.

    PMID: 12357146BACKGROUND

  • Muhlbacher J, Luf F, Zotti O, Herkner H, Fleischmann E, Kabon B. Effect of Intraoperative Goal-Directed Fluid Management on Tissue Oxygen Tension in Obese Patients: a Randomized Controlled Trial. Obes Surg. 2021 Mar;31(3):1129-1138. doi: 10.1007/s11695-020-05106-x. Epub 2020 Nov 27.

    PMID: 33244655DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Kabon, MD

    MUW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD. MD.

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

AU(1)