[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.


METHODS
Descriptive.


METHODS
Department of intensive care, Academic Medical Centre, Amsterdam.


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).


CONCLUSIONS
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.
Costongs
L G
LG
Afd. Intensive Care, Academisch Medisch Centrum, Amsterdam.
Speelman
P
P
van Lieshout
J J
JJ
van Deventer
S J
SJ
Lubbers
M J
MJ
Schipper
H G
HG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic; D004731:Endotoxins / Q000276:immunology; D005260:Female; D016905:Gram-Negative Bacterial Infections / Q000150:complications / Q000628:therapy; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000628:therapy; D018805:Sepsis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D012720:Severity of Illness Index; D012772:Shock, Septic / Q000628:therapy
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D004731:Endotoxins; D007074:Immunoglobulin G; C068069:nebacumab