Comparison of HES 130 in Balanced and in Unbalanced Solution

B. Braun

Status and phase

Completed

Phase 3

Conditions

Decreased and Nonspecific Blood Pressure Disorders and Shock

Treatments

Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution

Drug: 6% HES 130/0.4 in a saline solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01301469

HC-G-H-0801

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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