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Goal Directed Fluid Therapy (FLO1)

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ClinicalTrials.gov Identifier: NCT00860704
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Andrea Holzer, Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Goal Directed Fluid Therapy Other: fluidotherapy with ringer-lactate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients
Study Start Date : November 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860704


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

Publications:
Responsible Party: Andrea Holzer, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00860704     History of Changes
Other Study ID Numbers: EK 299/2006
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

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