Score-based immunoglobulin G therapy of patients with sepsis: the SBITS study.

OBJECTIVE: Intravenous immunoglobulin as an adjunctive treatment in sepsis was regarded as promising by a Cochrane meta-analysis of smaller trials. In this phase III multicenter trial, we assessed whether intravenous immunoglobulin G (ivIgG) reduced 28-day mortality and improved morbidity in patients with score-defined severe sepsis. DESIGN: Randomized, double-blind, placebo-controlled, multicenter trial. SETTING: Twenty-three medical and surgical intensive care units in university centers and large teaching hospitals. PATIENTS: Patients (n = 653) with score-defined sepsis (sepsis score 12-27) and score-defined sepsis-induced severity of disease (Acute Physiology and Chronic Health Evaluation II score 20-35). INTERVENTIONS: Patients were assigned to receive either placebo or ivIgG (day 0, 0.6 g/kg body weight; day 1, 0.3 g/kg body weight). MEASUREMENTS AND MAIN RESULTS: The prospectively defined primary end point was death from any cause after 28 days. Prospectively defined secondary end points were 7-day all-cause mortality, short-term change in morbidity, and pulmonary function at day 4. Six hundred fifty-three patients from 23 active centers formed the intention-to-treat group, 624 patients the per-protocol group (placebo group, n = 303; ivIgG group, n = 321). The 28-day mortality rate was 37.3% in the placebo group and 39.3% in the ivIgG group and thus not significantly different (p = .6695). Seven-day mortality was not reduced, and 4-day pulmonary function was not improved. Drug-related adverse events were rare in both groups. Exploratory findings revealed a 3-day shortening of mechanical ventilation in the surviving patients and no effect of ivIgG on plasma levels of interleukin-6 and tumor necrosis factor receptors I and II. CONCLUSIONS: In patients with score-defined severe sepsis, ivIgG with a total dose of 0.9 g/kg body weight does not reduce mortality.

[The importance of the parameter sex & gender in anesthesia and intensive care medicine dealing with patients under alcohol influence]. / Die Bedeutung des Parameters Geschlecht im Umgang mit alkoholisierten PatientInnen in der Anästhesie und Intensivmedizin.

Alcoholised females and males belong to a specific group of risk patients in anesthesia and intensive care medicine. Knowledge about effects touching the interaction of chronic alcohol consumption and acute alcohol abuse with other drugs is on a very low level. The assessment of risk depends on several factors. In addition to the judgement of grades of seriousness of an alcohol intoxication the parameter of sex and gender can be seen as much a prominent parameter as age, morbidity, and co-morbidity. This thesis is confirmed by some significant sex-based biological differences related to biological effects of alcohol consumption and differences in pharmacodynamics and pharmacokinetics of anesthetics. The high rate of injuries and accidents under the influence of alcohol, strongly recommends the detection of a sex- and gender-sensitive approach by anesthesia and intensive care medicine to patients with chronic or acute alcohol abuse.