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document
Efficacy and safety of 10 % HES 130/0.4 versus 10 % HES 200/0.5 for plasma volume expansion in cardiac surgery patients . AIM Hydroxyethyl starch ( HES ) solutions are frequently used for perioperative volume replacement . Whereas older HES specimen tended to accumulate in the plasma and to cause negative effects on hemostasis , more recent products , e.g. , HES 130/0.4 , are characterised by improved pharmacological properties . The present study was designed to compare the efficacy and safety of 10 % HES 130/0.4 and 10 % HES 200/0.5 . METHODS In this post-hoc analysis of a prospective , randomised , double-blind , multi-center therapeutic equivalence trial , 76 patients undergoing elective on-pump cardiac surgery received perioperative volume replacement using either 10 % HES 130/0.4 ( N.=37 ) or 10 % HES 200/0.5 ( N.=39 ) up to a maximum dose of 20 mL kg-1 . RESULTS Equivalent volumes of investigational medication were infused until 24 hours after the first administration ( 1577 vs. 1540 mL ; treatment difference 37 [ -150 ; 223 ] mL ; P < 0.0001 for equivalence ) . Whereas standard laboratory tests of coagulation were comparable between groups , von Willebrand factor activity on the first postoperative morning tended to be higher following treatment with 10 % HES 130/0.4 as compared to 10 % HES 200/0.5 ( P=0.025 ) with this difference being statistically significant only in the per-protocol analysis ( P=0.02 ) . Treatment groups were comparable concerning other safety parameters and the incidence of adverse drug reactions . In particular , renal function was well preserved in both groups . CONCLUSION Ten percent HES 130/0.4 was equally effective and safe as compared to 10 % HES 200/0.5 for volume therapy in patients undergoing cardiovascular surgery . Postoperative coagulation and renal function , as measured by standard laboratory tests , were similar among groups .
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Intervention_Pharmacological
HES
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Intervention_Pharmacological
HES
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Intervention_Pharmacological
Hydroxyethyl starch
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Intervention_Pharmacological
perioperative volume replacement using either 10 % HES 130/0.4 ( N.=37 ) or 10 % HES 200/0.5 ( N.=39 ) up to a maximum dose of 20 mL kg-1 .
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Outcome_Other
Efficacy and safety
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Other
Equivalent volumes of investigational medication
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Outcome_Physical
standard laboratory tests of coagulation
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Outcome_Physical
von Willebrand factor activity
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Outcome_Other
safety parameters
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Outcome_Adverse-effects
incidence of adverse drug reactions
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Outcome_Physical
renal function
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Outcome_Physical
Postoperative coagulation and renal function