Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions

Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective Surgery

The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.

Inclusion:

• patients scheduled to undergo elective surgery of the pancreatic head
• patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Exclusion:

• patients of American Society of Anesthesiologists (ASA) class > III
• heart failure defined as New York Heart Association (NYHA) class>2
• aneurysm of the ascending and thoracic aorta
• patients with Zenker's diverticle
• local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch)
• patients receiving haemodialysis
• patients with known bleeding diatheses
• any bleeding disorder known from patient's history
• patients with a haematocrit <= 25% despite pre-operative transfusion
• renal insufficiency (serum creatinine > 130 µmol/l or >1.5 mg/dl) or oliguria or anuria
• impaired hepatic function defined as Mayo End-Stage Liver Disease (MELD) > 10 or liver cirrhosis Child-Pugh B or C
• additional contra-indications for investigational products