Influence of a long-term, high-dose volume therapy with 6% hydroxyethyl starch 130/0.4 or crystalloid solution on hemodynamics, rheology and hemostasis in patients with acute ischemic stroke. Results of a randomized, placebo-controlled, double-blind study.
BACKGROUND
This study was performed to investigate the clinical effects of a 4-day volume therapy with a newly developed, 6% hydroxyethyl starch (HES) 130/0.4 versus crystalloid solution, with particular regard to systemic and cerebral hemodynamics, rheology and safety.


METHODS
In a randomized, double-blind study, 40 patients suffering from an acute ischemic stroke received either 6% HES 130/0.4 or crystalloid solution as continuous infusion over 4 days with a total dose of 6.5 liters. Efficacy parameters studied included hemodynamics (cardiac output, blood pressure, flow velocity with transcranial Doppler) and rheology (hematocrit and plasma viscosity). Safety parameters examined included laboratory, hemostaseology (including factor VIII) and an adverse event questionnaire (including pruritus).


RESULTS
In both groups, a small, but not significant increase in cardiac output was observed. There were no significant changes regarding the remaining efficacy or safety parameters, except for the well-known increase in serum alpha-amylase through the infusion of HES.


CONCLUSIONS
In our study with patients suffering from acute ischemic stroke, continuous infusion (1 ml/min) of HES 130/0.4 or crystalloid solution did not differ regarding safety or hemodynamic efficacy.
Woessner
Ralph
R
Department of Neurology, Westpfalz Klinikum, University City of Kaiserslautern, Kaiserslautern, Germany.
Grauer
Markus T
MT
Dieterich
Hans-Jürgen
HJ
Bepperling
Frank
F
Baus
Daniela
D
Kahles
Timo
T
Georgi
Sven
S
Bianchi
Oliver
O
Morgenthaler
Martin
M
Treib
Johannes
J
D002545:Brain Ischemia / Q000097:blood / Q000188:drug therapy; D002302:Cardiac Output / Q000187:drug effects; D000077324:Crystalloid Solutions; D004311:Double-Blind Method; D006439:Hemodynamics / Q000187:drug effects*; D018056:Hemorheology / Q000187:drug effects; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage* / Q000633:toxicity; D007552:Isotonic Solutions; D010952:Plasma Substitutes / Q000008:administration & dosage* / Q000633:toxicity; D020521:Stroke / Q000097:blood / Q000188:drug therapy*; D013810:Therapeutic Equivalency; D013997:Time Factors
D000077324:Crystalloid Solutions; D006895:Hydroxyethyl Starch Derivatives; D007552:Isotonic Solutions; D010952:Plasma Substitutes