Goal Directed Fluid Therapy

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

Detailed Description
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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.

Official Title
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Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Conditions
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Goal Directed Fluid Therapy

Intervention / Treatment
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* Drug: fluidotherapy with ringer-lactate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ringerlactate lean<br>fluidtherapy with crystalloids in lean patients | Drug: fluidotherapy with ringer-lactate<br>* a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler<br>|
| Active Comparator: Ringerlactate overweight<br>fluidtherapy with crystalloids in overweight patients | Drug: fluidotherapy with ringer-lactate<br>* a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler<br>|
| Active Comparator: Ringerlactate obese<br>fluidtherapy with crystalloids in obese patients | Drug: fluidotherapy with ringer-lactate<br>* a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| different hemodynamic fluid responses in the different groups |  | every 10 minutes during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous oxygen tension (PsqO2) |  | every 10 minutes during surgery and 2 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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goal directed fluid therapy, lean patients, obese patients, crystalloids, Esophageal Doppler, tissue oxygenation, Fluid management during surgery, Fluid management