Clinical trial NCT00554944: Intraoperative Goal-directed Fluid Management
Official title: Intraoperative Goal-directed Fluid Management in Lean and Obese Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Abdominal Surgery
Hysterectomy
Genital Prolapse
Keywords: Fluid Management
surgery
Obesity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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 .
timeFrame: July, 2009
Secondary outcomes:
measure: To identify whether tissue oxygenation is similar in lean, overweight, obese and morbidly obese patients when perioperative fluid management is optimized.
timeFrame: July, 2008
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Leif Saager, MD
role: PRINCIPAL_INVESTIGATOR
References: