Intraoperative Goal-directed Fluid Management

NCT00554944 | Withdrawn DMC

• 1 other identifier: 07-409
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Abdominal Surgery; Hysterectomy; Genital Prolapse

Keywords

Fluid Management; surgery; Obesity

Outcome Measures

Primary Outcomes (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 .

  July, 2009

Secondary Outcomes (1)

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

  July, 2008

Interventions

Esophageal probe PROCEDURE

Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, aged \> 18 years old
• Scheduled for elective, open abdominal or vaginal hysterectomies.
• Patients will be recruited in the following body mass index categories:
• BMI \[kg/m2\]
• BMI \[kg/m2\]
• BMI \[kg/m2\]
• BMI \[kg/m2\]
• BMI \[kg/m2\]
• \> 45 BMI \[kg/m2\]

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY DIRECTOR

• Leif Saager, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

US (1)