Intensivmedizin Fragen und Antworten
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13 · Klinische Studien<br />
183<br />
13<br />
Conclusions High-dose antithrombin III therapy had no effect on 28-day allcause<br />
mortality in adult patients with severe sepsis and septic shock when administered<br />
within 6 hours after the onset. High-dose antithrombin III was<br />
associated with an increased risk of hemorrhage when administered with heparin.<br />
There was some evidence to suggest a treatment benefit of antithrombin<br />
III in the subgroup of patients not receiving concomitant heparin.<br />
Fazit<br />
Die hoch dosierte Antithrombingabe hatte keinen Einfluss auf die 28-Tage-Letalität<br />
von Patienten mit schwerer Sepsis <strong>und</strong> septischem Schock.<br />
jHoch dosierte Antithrombingabe bei Patienten mit schwerer Sepsis<br />
<strong>und</strong> hohem Sterblichkeitsrisiko: Wirksamkeit <strong>und</strong> Sicherheit<br />
(Subgruppenanalyse KyberSept-Studie)<br />
(n=1008 Patienten, prospektive <strong>und</strong> randomisierte Studie, Subgruppenanalyse)<br />
Wiedermann CJ, Hoffmann JN, Juers M, Ostermann H, Kienast J, Briegel J, Strauss R,<br />
Keinecke HO, Warren BL, Opal SM; KyberSept Investigators (2006) High-dose antithrombin<br />
III in the treatment of severe sepsis in patients with a high risk of death: efficacy and<br />
safety. Crit Care Med 34: 285–92<br />
Objective To explore if patients with severe sepsis and with a predicted high<br />
risk of death (according to the Simplified Acute Physiology Score II) might have<br />
a treatment benefit from high-dose antithrombin III.<br />
Design Subgroup analysis of a randomized, placebo-controlled, double-blind,<br />
prospective phase III study.<br />
Setting Unifactorial and multifactorial reanalysis of prospectively defined<br />
populations from the KyberSept trial.<br />
Patients We studied 1,008 patients (43.6 % of the overall intention-to-treat<br />
population, n=2,314) with a predicted mortality rate of 30–60 % at study entry<br />
as defined by the Simplified Acute Physiology Score II.<br />
Interventions Patients were randomized in a 1:1 fashion to receive either highdose<br />
antithrombin III (30,000 IU intravenously over the period of 4 days) or<br />
placebo.<br />
Measurements and Main Results In a Kaplan-Meier analysis of patients with<br />
a predicted mortality of 30–60 %, the survival time when followed up for 90<br />
days after admission was increased in the high-dose antithrombin III group
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