[Immunotherapy using the anti-endotoxin antibody HA-1A (Centoxin) in patients with sepsis syndrome; fair results following protocol selection of patients].

OBJECTIVE

Evaluation of HA-1A treatment in patients with the sepsis syndrome.

DESIGN

Descriptive.

SETTING

Department of intensive care, Academic Medical Centre, Amsterdam.

PATIENTS AND METHODS

Intensive-care patients with the sepsis syndrome and shock or organ failure with a presumptive diagnosis of Gram-negative infection were eligible for treatment with HA-1A. We analysed and compared the results with those of the double-blind, randomized HA-1A study by Ziegler et al.

RESULTS

Between May 1991 and March 1992, 27 patients were treated with HA-1A. The mortality rate was 59% (16/27). Among the 11 patients with a Gram-negative bacteraemia mortality was 7/11, much higher than in the Ziegler study (30%). In comparison with the HA-1A study we selected sicker patients: the mean APACHE II score was higher, 93% of our patients were in shock and 85% had organ failure. More patients presented with an intra-abdominal sepsis and mortality in this group was very high (11/14). In patients with a Gram-negative bacteraemia the delay between the onset of the sepsis syndrome and the administration of HA-1A was longer (median 22 h versus 14.3 h in the Ziegler study, mean 30 versus 20 h).

CONCLUSION

HA-1A does not appear to be beneficial in critically ill patients with a longstanding sepsis syndrome, especially not if an intra-abdominal sepsis is apparent. Therefore, we decided not to use H-1A until additional data become available. Additional objective inclusion criteria are needed to improve the identification of the patient group that may benefit from treatment with HA-1A.