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Goal Directed Fluid Therapy

Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00860704
Acronym
FLO1
Enrollment
90
Registered
2009-03-12
Start date
2007-11-30
Completion date
2012-12-31
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Goal Directed Fluid Therapy

Keywords

goal directed fluid therapy, lean patients, obese patients, crystalloids, Esophageal Doppler, tissue oxygenation, Fluid management during surgery, Fluid management

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.

Interventions

DRUGfluidotherapy with ringer-lactate

a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
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 * NYHA IV * infection * sepsis * history of suspect malignant hyperthermia * porphyria

Design outcomes

Primary

MeasureTime frame
different hemodynamic fluid responses in the different groupsevery 10 minutes during surgery

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026