Obesity Clinical Trial
Official title:
Intraoperative Goal-directed Fluid Management in Lean and Obese Patients
Verified date | January 2017 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |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) |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
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 |
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