Skip to main content
Clinical Trials/NCT00860704
NCT00860704
Completed
Phase 4

Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Medical University of Vienna1 site in 1 country90 target enrollmentNovember 2007

Overview

Phase
Phase 4
Intervention
fluidotherapy with ringer-lactate
Conditions
Goal Directed Fluid Therapy
Sponsor
Medical University of Vienna
Enrollment
90
Locations
1
Primary Endpoint
different hemodynamic fluid responses in the different groups
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.

Detailed Description

To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI \<25) vs. obese patients (BMI \>25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
December 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Holzer

MD

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)

Exclusion Criteria

  • cardiac insufficiency (EF\< 35%)
  • renal insufficiency (creatinin clearance \<30ml/min, dialysis)
  • insulin dependant diabetes mellitus
  • coagulopathy
  • infection
  • history of suspect malignant hyperthermia
  • porphyria

Arms & Interventions

Ringerlactate lean

fluidtherapy with crystalloids in lean patients

Intervention: fluidotherapy with ringer-lactate

Ringerlactate overweight

fluidtherapy with crystalloids in overweight patients

Intervention: fluidotherapy with ringer-lactate

Ringerlactate obese

fluidtherapy with crystalloids in obese patients

Intervention: fluidotherapy with ringer-lactate

Outcomes

Primary Outcomes

different hemodynamic fluid responses in the different groups

Time Frame: every 10 minutes during surgery

Secondary Outcomes

  • Subcutaneous oxygen tension (PsqO2)(every 10 minutes during surgery and 2 hours postoperatively)

Study Sites (1)

Loading locations...

Similar Trials