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Intraoperative Goal-directed Fluid Management

Primary Purpose

Obesity, Abdominal Surgery, Hysterectomy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal probe
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Fluid Management, surgery, Obesity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cleveland Clinic

Outcomes

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 .

Secondary Outcome Measures

To identify whether tissue oxygenation is similar in lean, overweight, obese and morbidly obese patients when perioperative fluid management is optimized.

Full Information

First Posted
November 6, 2007
Last Updated
January 20, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00554944
Brief Title
Intraoperative Goal-directed Fluid Management
Official Title
Intraoperative Goal-directed Fluid Management in Lean and Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
not progressing as anticipated
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal Surgery, Hysterectomy, Genital Prolapse
Keywords
Fluid Management, surgery, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Esophageal probe
Intervention Description
Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women, aged > 18 years old Scheduled for elective, open abdominal or vaginal hysterectomies. Patients will be recruited in the following body mass index categories: 18.5-24.9 BMI [kg/m2] 25.0-29.9 BMI [kg/m2] 30.0-34.9 BMI [kg/m2] 35.0-39.9 BMI [kg/m2] 40.0-44.9 BMI [kg/m2] > 45 BMI [kg/m2] Exclusion Criteria: Hysterectomies due to gynecologic cancer diagnosis Signs and/or symptoms of decompensate heart failure End-stage renal disease History of susceptibility to malignant hyperthermia or porphyria Esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel I Sessler, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leif Saager, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Intraoperative Goal-directed Fluid Management

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