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Goal Directed Fluid Therapy (FLO1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00860704
First received: March 11, 2009
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  Purpose

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


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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subcutaneous oxygen tension (PsqO2) [ Time Frame: every 10 minutes during surgery and 2 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2007
Estimated Study Completion Date: December 2012
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • NYHA IV
  • infection
  • sepsis
  • history of suspect malignant hyperthermia
  • porphyria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860704

Contacts
Contact: Andrea Holzer, MD 0140400 ext 4107 andrea.holzer@meduniwien.ac.at
Contact: Edith Fleischmann, MD 0140400 ext 4107 edith.fleischmann@meduniwien.ac.at

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Andrea Holzer, MD     0140400 ext 4107     andrea.holzer@meduniwien.ac.at    
Contact: Edith Fleischmann, MD     0140400 ext 4107     edith.fleischmann@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Andrea Holzer, MD Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
  More Information

Publications:

Responsible Party: Andrea Holzer, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00860704     History of Changes
Other Study ID Numbers: EK 299/2006
Study First Received: March 11, 2009
Last Updated: May 11, 2011
Health Authority: Austria: Federal Ministry for Health Family and Youth

Keywords provided by Medical University of Vienna:
goal directed fluid therapy
lean patients
obese patients
crystalloids
 Esophageal Doppler
tissue oxygenation
Fluid management during surgery
Fluid management

ClinicalTrials.gov processed this record on May 16, 2013