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

简要总结

主要结局

次要结局

• Major post-operative complications(until post-operative day 90)
• Mortality(1 year)
• Composite of mortality and major post-operative complications (including renal)(until post-operative day 90)
• Total volume of administered investigational product(until 24 hours after investigational product treatment start)
• Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss](until post-operative day 3)
• Heart Rate(until post-operative day 3)
• Renal function(until 1 year after surgery)
• Calculated red blood cell (RBC) loss(on post-operative day 3)
• Inflammation(until post-operative day 1)
• Estimated intra-operative blood loss(end of surgery)
• Coagulation(until post-operative day 1)
• Adverse events(until post-operative day 90)
• Body temperature(until post-operative day 3)
• Mean arterial pressure(until post-operative day 3, if available)
• Systolic arterial blood pressure(until end of surgery)
• Diastolic arterial blood pressure(until end of surgery)
• Central venous pressure (if available)(until end of surgery)
• Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration](until 24 hours after investigational product treatment start)
• Partial pressure of carbon dioxide(until end of surgery)
• Partial pressure of oxygen(until end of surgery)
• Bicarbonate(until end of surgery)
• Arterial oxygen saturation(until end of surgery)
• Haemoglobin(until post-operative day 3)
• Haematocrit(until post-operative day 3)
• pH(until end of surgery)
• Base Excess(until end of surgery)
• Lactate(until post-operative day 3)
• Central venous oxygen saturation (if available)(until post-operative day 1)
• Serum sodium(until post-operative day 1)
• Serum potassium(until post-operative day 1)
• Serum calcium(until post-operative day 1)
• Serum chloride(until post-operative day 1)
• Length of stay in the hospital/intensive care unit(until post-operative day 90)
• Hours on mechanical ventilation(until post-operative day 7)