Supplemental immunoglobulin (ivIgG) treatment in 163 patients with sepsis and septic shock--an observational study as a prerequisite for placebo-controlled clinical trials.
In a multicenter observational study of 163 medical and surgical patients with a total of 173 episodes of sepsis or septic shock (Elebute sepsis score: 19.0 +/- 0.5), the effects of supplemental i.v. immunoglobulin (i.v. IG) treatment (unmodified polyvalent IgG pH 4.25, n = 123; for Pseudomonas sepsis, n = 50, Pseudomonas IgG) on multiple organ failure (MOF) were investigated by means of APACHE II score changes (pretreatment: 23.7 +/- 0.6). In 44% of the cases ("responders"), a prompt improvement in APACHE II score (defined as decrease greater than or equal to 4) was evident from day 0 to day 4 after onset of therapy, thus being in close time relationship to the i.v. IG administration. This improvement, associated with a better prognosis (mortality 24% vs. 55%), was found in all subgroups, most importantly the following: polyvalent IgG vs. Pseudomonas IgG treatment; medical vs. surgical patients; moderate vs. severe MOF; and gram-positive vs. gram-negative septicemia. In a small-sized second comparative nonrandomized control group (n = 27, antibiotic treatment alone) of septic patients (Elebute: 14.7 +/- 1.0) with similar MOF severity (APACHE II: 23.6 +/- 1.4), the response rate (30%) was, though not statistically significant, lower by one-third. The optimal baseline score ranges for patient inclusion into future placebo-controlled randomized i.v. IG trials were found to be 20-35 for the APACHE II score and 12-27 for the Elebute score.
Pilz
G
G
Medizinische Klinik I, Klinikum Grosshadern der Universität München, Germany.
Kääb
S
S
Neeser
G
G
Class
I
I
Schweigart
U
U
Brähler
A
A
Bujdoso
O
O
Neumann
R
R
Werdan
K
K
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003422:Critical Care; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011379:Prognosis; D018805:Sepsis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D012720:Severity of Illness Index; D012772:Shock, Septic / Q000401:mortality / Q000628:therapy*
D000900:Anti-Bacterial Agents; D007074:Immunoglobulin G