Goal Directed Fluid Therapy (FLO1)

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Goal Directed Fluid Therapy

Treatments: Drug: fluidotherapy with ringer-lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT00860704

EK 299/2006

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Ringerlactate lean

Active Comparator group

Description:

fluidtherapy with crystalloids in lean patients

Treatment:

Drug: fluidotherapy with ringer-lactate

Ringerlactate overweight

Active Comparator group

Description:

fluidtherapy with crystalloids in overweight patients

Treatment:

Drug: fluidotherapy with ringer-lactate

Ringerlactate obese

Active Comparator group

Description:

fluidtherapy with crystalloids in obese patients

Treatment:

Drug: fluidotherapy with ringer-lactate