Intraoperative Goal-directed Fluid Management
Procedure: Esophageal probe
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Intraoperative Goal-directed Fluid Management in Lean and Obese Patients|
- To develop a statistical equation based on the BMI (Body Mass Index) that predicts fluid requirements in individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair . [ Time Frame: July, 2009 ] [ Designated as safety issue: No ]
- To identify whether tissue oxygenation is similar in lean, overweight, obese and morbidly obese patients when perioperative fluid management is optimized. [ Time Frame: July, 2008 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||February 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Procedure: Esophageal probe
Recent evidence suggests that goal-directed fluid management using stroke volume (blood ejected by the heart) is the most physiologic approach for fluid replacement. We propose to develop a body mass index (BMI)-specific fluid replacement formula based on stroke volume guidance.
Arterial pulse pressure variation (dPP) induced by mechanical ventilation is a proposed predictor of fluid responsiveness as well. We will therefore also investigate if stroke volume (measured by esophageal Doppler monitoring) and pulse pressure variation comparably predict fluid responsiveness by simultaneously measuring both parameters.
Adequate tissue oxygenation is essential to maintain normal physiologic functions. Fat tissue oxygenation is critically low in the obese surgical patient. It is likely that poor fat tissue oxygenation results in part from inadequate fluid replacement. We propose to determine if fat tissue oxygenation is comparable from lean to morbidly obese patients when fluid replacement is optimized.
Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be assigned to six groups according to BMI, from lean to morbidly obese categories. The primary aim will be to develop a statistical equation for predicting fluid requirements as a function of BMI. A maximum of 100 patients will be able to detect an R-squared of 10% or more with 90% power at the 0.05 significance level, and will enable adequate estimation of the relationship of interest.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554944
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Daniel I Sessler, MD||The Cleveland Clinic|
|Principal Investigator:||Leif Saager, MD||The Cleveland Clinic|