Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

Inclusion:

• Male or female adult patients > 40 and ≤ 85 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
• Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml
• ASA Physical Status II - III
• Signed written informed consent form

Exclusion:

• Hypersensitivity to the active substances or to any of the other excipients of the investigational medicinal products
• Body weight ≥ 140 kg
• Sepsis
• Burns
• Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic renal replacement therapy
• Intracranial or cerebral haemorrhage
• Critically ill patients (typically admitted to the intensive care unit)
• Hyperhydration
• Pulmonary oedema
• Dehydration
• Hyperkalaemia
• Severe hypernatraemia
• Severe hyperchloraemia
• Severely impaired hepatic function
• Congestive heart failure
• Severe coagulopathy
• Organ transplant patients
• Metabolic alkalosis
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)