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Intraoperative Goal-directed Fluid Management

This study has been terminated.
(not progressing as anticipated)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00554944
First received: November 6, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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 Intervention
Obesity
Abdominal Surgery
Hysterectomy
Genital Prolapse
Procedure: Esophageal probe

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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)
Intervention Details:
    Procedure: Esophageal probe
    Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554944

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

No publications provided

Responsible Party: Leif Saager. M.D., Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00554944     History of Changes
Other Study ID Numbers: 07-409
Study First Received: November 6, 2007
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Fluid Management
surgery
Obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014