ABSTRACT
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.
Subject(s)
Immunoglobulin G/therapeutic use , Sepsis/therapy , Shock, Septic/therapy , Adult , Aged , Anti-Bacterial Agents/therapeutic use , Combined Modality Therapy , Critical Care , Humans , Immunoglobulin G/administration & dosage , Middle Aged , Prognosis , Sepsis/etiology , Sepsis/mortality , Severity of Illness Index , Shock, Septic/mortalityABSTRACT
This paper describes a program for bedside-practicable calculation of APACHE II score, providing an additional option for both a rapid and sensitive screening as well as for a more specific sepsis assessment by the Elebute score in case of a putative diagnosis of sepsis. Thus, diagnostic and prognostic evaluation of septic patients and the assessment of disease progression and classification of "responders" to therapy can be promptly available in the ICU setting. The program is written in BASIC and therefore can easily be adapted to most microcomputers available on the market.
Subject(s)
Bacterial Infections/diagnosis , Critical Care , Severity of Illness Index , Software , Humans , Mathematical Computing , Microcomputers , ROC Curve , Software DesignABSTRACT
The impact of i.v. immunoglobulin (IVIG) therapy on the survival of adult septic patients cannot yet be considered either proved or disproved. To define optimal criteria for a large multicenter placebo-controlled trial, a multicenter observational study was carried out in 163 medical and surgical patients exhibiting a total of 173 episodes of sepsis and septic shock [Elebute (El) sepsis score; 19 +/- 0.5). The effects of supplemental IVIG treatment (unmodified polyvalent IgG, pH 4.25, n = 123; for Pseudomonas sepsis, n = 50, Pseudomonas IgG) on multiple-organ failure (MOF) were investigated according to changes in the APACHE II score (AP) (pretreatment value 23.7 +/- 0.6). In 44% of the cases ("responders"), a prompt improvement in AP (defined as a decrease of greater than or equal to 4) was evident from day 0 to day 4 after the onset of therapy, thus showing a close temporal relationship to IVIG administration. This improvement, associated with an improved prognosis (mortality, 24% vs 55%), was found in all subgroups, most importantly, polyvalent IgG vs Pseudomonas IgG treatment; medical vs surgical patients; moderate vs severe MOF; and gram-positive vs gram-negative septicemia. Thus, all of these patients should be included in future placebo-controlled, randomized IVIG trials.(ABSTRACT TRUNCATED AT 250 WORDS)
