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Goal Directed Fluid Therapy (FLO1)

This study has been completed.
Information provided by (Responsible Party):
Andrea Holzer, Medical University of Vienna Identifier:
First received: March 11, 2009
Last updated: April 6, 2015
Last verified: April 2015
Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.

Condition Intervention Phase
Goal Directed Fluid Therapy
Other: fluidotherapy with ringer-lactate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • different hemodynamic fluid responses in the different groups [ Time Frame: every 10 minutes during surgery ]

Secondary Outcome Measures:
  • Subcutaneous oxygen tension (PsqO2) [ Time Frame: every 10 minutes during surgery and 2 hours postoperatively ]

Enrollment: 90
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: crystalloids lean
fluidotherapy with crystalloids in lean patients
Other: fluidotherapy with ringer-lactate
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
Active Comparator: crystalloids obese
fluidotherapy with crystalloids in obese patients
Other: fluidotherapy with ringer-lactate
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  • sepsis
  • history of suspect malignant hyperthermia
  • porphyria
  Contacts and Locations
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Please refer to this study by its identifier: NCT00860704

Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Andrea Holzer, MD Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
  More Information

Responsible Party: Andrea Holzer, MD, Medical University of Vienna Identifier: NCT00860704     History of Changes
Other Study ID Numbers: EK 299/2006
Study First Received: March 11, 2009
Last Updated: April 6, 2015

Keywords provided by Medical University of Vienna:
goal directed fluid therapy
lean patients
obese patients
Esophageal Doppler
tissue oxygenation
Fluid management during surgery
Fluid management processed this record on April 28, 2017