Intraoperative Goal-Directed Fluid Therapyin Lean and Obese Patients - n.A

Conditions: Hemodynamics in obese patients differ from lean patients: Obese patients have a higher cardiac output, the absolute amount of their intravascular volume is increased, as is the intracellular volume. The impact of these pathophysiological changes on perioperative fluid therapy is not known. Fluid optimisation has been considered as major contributor to improved oxygen delivery in patients. Hypovolemia has been associated with significant increases in morbidity and mortality.

Registration Number: EUCTR2006-002333-21-AT

Lead Sponsor: Allgemeines Krankenhaus Wien, Medizinische Un iversität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 40

Inclusion Criteria

After IRB approval and written informed consent patients, aged 18-80, and scheduled consecutively for elective abdominal hysterectomy or myomectomy will be included in the study. Patients will be assigned to four groups.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

We will exclude patients having cardiac (ejection fraction<35%) or renal insufficiency (creatinine clearance < 30ml/min, or on renal replacement therapy), coronary (NYHA IV) or peripheral artery disease, insulin dependent diabetes mellitus, coagulopathies, symptoms of infection or sepsis, or a history of susceptibility to malignant hyperthermia or porphyria. Participants in other studies will be excluded, when an interference of the studies cannot be ruled out.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare lean patients (Body Mass Index [BMI] <25) vs. obese patients (BMI >30) in regard of their respective needs for intraoperative fluid therapy. <br><br><br>;Secondary Objective: To compare crystalloids (Lactated Ringer’s solution [LR]) vs. colloids (Hydroxyaethylstarch Haes 6% 130/0.4 [Voluven®]) as intraoperative fluid therapy directed by predetermined goals. ;Primary end point(s): Tissue Oxgen Tension after Surgery<br>Amount of volume requirement

Secondary Outcome Measures