Comparison of HES 130 in Balanced and in Unbalanced Solution

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG
• Treatments: Pharmaceutical Solutions

Criteria

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