Comparison of HES 130 in Balanced and in Unbalanced Solution

Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients

The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.

Inclusion:

• Male or female (non pregnant) patients; between 18 and 70 years
• Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
• General anesthesia
• Voluntary consent

Exclusion:

• Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
• BMI < 18 or > 29
• Patients with daily urine output < 1L
• Patients on hemodialysis
• Abnormal liver or renal function (i. e. above upper limit of normal range)
• Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)
• Hgb < 10g/dl or HCT < 30%
• Potassium, sodium or chloride above the upper limit of normal of the laboratory
• History of diabetes mellitus
• Known history of a mental or neurological disorder, such as epileptic seizures.
• History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation
• Patients with known hypersensitivity and with contraindications to HES or any of the excipients