Comparison of Volulyte® versus Tetraspan® in patients undergoing cardiopulmonary bypass.

INTERVENTION: Trade Name: Tetraspan ® Pharmaceutical Form: Solution for infusion CAS Number: 8000006‐02‐2 Other descriptive name: STARCH POTATO Trade Name: Volulyte® Pharmaceutical Form: Solution for infusion CAS Number: 8000006‐00‐0 Other descriptive name: STARCH MAIZE CONDITION: coagulation status, colloid oncotic pressure (COP) and ion‐ and acid‐base balance. Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: Main Objective: Does the use of two different balanced hydroxyethyl starch solutions, influence the coagulation profile, acid‐base status, ionogram, colloid oncotic pressure? Primary end point(s): Coagulation profile, acid‐base status, ionogram, colloid oncotic pressure. Secondary Objective: Safety profile and outcome Timepoint(s) of evaluation of this end point: Induction of anesthesia, on CBP, after CBP and POD1 SECONDARY OUTCOME: Secondary end point(s): Organ function and outcome. Timepoint(s) of evaluation of this end point: POD1 INCLUSION CRITERIA: Adult patients undergoing cardiac surgery with cardiopulmonary bypass. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30