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Intraoperative Goal-directed Fluid Management

This study has been withdrawn prior to enrollment.
(not progressing as anticipated)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00554944
First received: November 6, 2007
Last updated: January 20, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 The Cleveland Clinic:

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 ]

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 ]

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: February 2010
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
The Cleveland Clinic
Investigators
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
Study First Received: November 6, 2007
Last Updated: January 20, 2017

Keywords provided by The Cleveland Clinic:
Fluid Management
surgery
Obesity

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 21, 2017