Intraoperative Goal-directed Fluid Management

Obesity Clinical Trial

Official title:

Intraoperative Goal-directed Fluid Management in Lean and Obese Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00554944
• Other study ID #: 07-409
• Status: Withdrawn
• Phase: N/A
• First received: November 6, 2007
• Last updated: January 20, 2017
• Start date: June 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to determine esophageal Doppler goal-directed fluid requirements in lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be eligible to participate

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Women, aged > 18 years old

2. Scheduled for elective, open abdominal or vaginal hysterectomies.

Patients will be recruited in the following body mass index categories:

1. 18.5-24.9 BMI [kg/m2]

2. 25.0-29.9 BMI [kg/m2]

3. 30.0-34.9 BMI [kg/m2]

4. 35.0-39.9 BMI [kg/m2]

5. 40.0-44.9 BMI [kg/m2]

6. > 45 BMI [kg/m2]

Exclusion Criteria:

1. Hysterectomies due to gynecologic cancer diagnosis

2. Signs and/or symptoms of decompensate heart failure

3. End-stage renal disease

4. History of susceptibility to malignant hyperthermia or porphyria

5. Esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration)

Related Conditions & MeSH terms

• Abdominal Surgery
• Genital Prolapse
• Hysterectomy
• Obesity
• Prolapse

Intervention

Procedure:
• Esophageal probe
Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .		July, 2009
Secondary	To identify whether tissue oxygenation is similar in lean, overweight, obese and morbidly obese patients when perioperative fluid management is optimized.		July, 2008