We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Intraoperative Goal-directed Fluid Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00554944
Recruitment Status : Withdrawn (not progressing as anticipated)
First Posted : November 7, 2007
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Obesity Abdominal Surgery Hysterectomy Genital Prolapse Procedure: Esophageal probe

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intraoperative Goal-directed Fluid Management in Lean and Obese Patients
Study Start Date : June 2007
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554944

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Study Director: Daniel I Sessler, MD The Cleveland Clinic
Principal Investigator: Leif Saager, MD The Cleveland Clinic
More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00554944     History of Changes
Other Study ID Numbers: 07-409
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by The Cleveland Clinic:
Fluid Management

Additional relevant MeSH terms:
Pathological Conditions, Anatomical