In patients at risk for sepsis after cardiac surgery the efficacy of intravenous immunoglobulin (Ig) treatment was compared with a historical superintendence population.

In patients at risk for sepsis after cardiac surgery the efficacy of intravenous immunoglobulin (Ig) treatment was compared with a historical superintendence population, equivalent in patient characteristics and disease severity. Using APACHE II scores we could discriminate between low-risk patients (score [les than] 19; mortality 1 percent) and the small clusters at risk (score 19 to 23) and high risk (score 24) with a significantly higher mortality (14 percent and 76 percent respectively). Subsequently among 1341 consecutive patients we prospectively identified and treated (IgG n = 41 IgGMA: n = 25) these at-risk assign places tos In contrast to have the direction ofs (risk: n = 21; high-risk; n = 21) we lay the foundation of a marked fall in n = 26; p [les than] 005; IgGMA, n = 13: p = 008) In this arrange Ig therapy produced higher (p [les than] 005) answer rates (score decrease 7 within 4 days: IgG: 54 percent IgGMA: 62 percent; controls: 19 percent) and reduc mortality (IgG: 46 percent IgGMA: 46 percent; controls: 76 percent) statistically significant (p [les than] 005) for Ig treatment overall. Thus, early Ig treatment improves disease severity and may improve prognosis in prospectively score-identified high-risk postcardiac surgical patients.

In patients after cardiac surgery the incidence of infections is high,[1] owed to cardiac impairment and the intraoperative use of extracorporeal circulation and its sequelae.[2-5] Accordingly, sepsis and septic multiple organ failure are among the major causes of death.[1,6,7]

Using the APACHE II score[8] for assessment of disease severity, we have shown that failure to improve promptly after heart surgery (criterion: score 19 forward the first postoperative day) was highly predictive for septic complications, associated with a significantly higher mortality.[7] in succession the other hand, a treatment-associated fall within a 4-day period in APACHE II scores in patients with sepsis has been demonstrated to lead to reduction in mortality according to more than 50 percent.[9] Using this score in the not absent study, we (1) prospectively identified postoperative cardiac surgical patients at risk and (2) investigated whether early supplemental sepsis treatment l to an improvement in disease severity and issue compared with a matching historical sway population. As supplemental sepsis treatment, we used intravenous (IV) immunoglobulin (Ig), which has been shown to cut short infections after cardiac surgery when given prophylactically.[10]

METHODS

thought Population and Treatment Regimen

The rule group consisted of all patients after elective open-heart surgery (excluding transplantation) at the Department of Cardiac Surgery Grosshadern Hospital, University of Munich, who during the period December 1988 to March 1989 and April 1990 to November 1990 had an APACHE II score of 19 upon the morning of the first postoperative day ("day 1") Part of this population had serv to establish the sepsis risk score prediction criterion (Fig 1a).[7] From December 1990 to June 1992 all patients fulfilling these criteria received an Ig preparation in an render free of access (nonblinded) manner. From December 1990 to October 1991 IV IgG (Psomaglobin N Tropon Biologische Praparate, eau-de-cologne Germany, dosage: day 1:8 ml/kg; day 2: 4 ml/kg) was used as standard Ig therapy regimen; from November 1991 to June 1992 IV IgGMA (Pentaglobin, Biotest, Dreieich, Germany, dosage: 5 ml/kg onward days 1, 2, and 3) was given. There was no restriction regarding standard therapy. All patients had given informed unison The protocol of this research was approved by the University of Munich Medical Faculty Ethics Committee.

Data Collection and Analysis

Parameters assessed to evaluate intergroup comparability are given in Table 1 Immunoglobulin evens were determined by nephelometric measurements in serum samples.

The main research end points were as follows: (1) the volume of APACHE II score-quantified improvement in disease severity; (2) the replication rate to therapy (defined as rate of patients with a decrease in APACHE II score of 7 from day 1 to day 5 [Table 2]; and (3) in-hospital mortality. Based forward the assumption that the Ig treatment weights were likely to be more distinct in the high-risk patients (APACHE II score 24 upon day 1 [Fig 1a]), these were chosen as the form into groups of primary interest.

Sample size considerations for nonrandomized comparative studies were done according to Makuch and Simon;x1;x1 for a power of 08 and significance of 005 Accordingly, for the high-risk dispose (control response rate: 19 percent) 26 treated patients were required to document an Ig therapy reply rate of 50 percent. After having attained this number for the IgG treatment, IgGMA was administered. This reflection was discontinued after inclusion of 13 high-risk patients given IgGMA (total: 25) since interim analysis revealed that the difference in replication rate vs controls had already reached statistical significance (Fig 2)

Differences between disposes were statistically analyzed using the [xsup2] trial with Yates' correction for categorical variables; for continuous variables, the Student's t proof for unpaired data or the Mann-Whitney U proof was used, where appropriate. Changes of values within arranges were analyzed using Scheffe's multiple range proof A p value of [les than] 005 was considered statistically significant. All values are given as mean [+ or -] 95 percent confidence interval for the mean.

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