Category Archives: Cardiac Surgery : Part 3

Early Sepsis Treatment With Immunoglobulins After Cardiac Surgery in Score-identified High-risk Patients – Effects of Ig Treatment

Early Sepsis Treatment With Immunoglobulins After Cardiac Surgery in Score-identified High-risk Patients - Effects of Ig TreatmentAfter score evaluation of risk (Fig 1a), we tested the efficacy of Ig as supplemental treatment. In contrast to the comparable historical cohort, we found a prompt and marked improvement in disease severity (fall in APACHE II score), especially in the high-risk group (Fig 1b; IgG: p<0.05; IgGMA: p=0.08). Immunoglobulin therapy also led to significantly (p<0.05) higher score response rates and a reduction in mortality (Fig 2), which was close to statistical significance for the IgG group (p=0.08; before Yates’ correction: 0.04). Exploratory analysis for Ig treatment as a whole (IgG and IgGMA) vs standard therapy (control) revealed a statistically significant (p<0.05) improvement in mortality rates. In the Ig group, the mean survival time of the nonsurvivors was 18.3 (1.0 to 35.6) days as opposed to 8.3 (4.0 to 12.6) days in the control group (p=NS). Expectedly, for the total risk population (risk plus high-risk), differences between treatment and control patients were not as distinct as in the high-risk group (Fig 2; nonsurvivors’ mean survival times: Ig: 17.4 (2.7 to 32.1) days; controls: 12.6 (4.8 to 20.4) days; (p=NS). No Ig treatment side effects were recorded. In both the control groups (standard therapy) and the Ig-treated patients, the separation into “responders” and “nonresponders” on the base of a fall in APACHE II score (see “Methods”) correlated significantly with mortality (Table 2).
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Early Sepsis Treatment With Immunoglobulins After Cardiac Surgery in Score-identified High-risk Patients – Data Collection and Analysis

Parameters assessed to evaluate intergroup comparability are given in Table 1. Immunoglobulin levels were determined by nephelometric measurements in serum samples.
The main study end points were as follows: (I) the extent of APACHE II score-quantified improvement in disease severity; (2) the response rate to therapy (defined as rate of patients with a decrease in APACHE II score of 7 from day I to day 5 [Table 2]; and (3) in-hospital mortality. Based on the assumption that the Ig treatment effects were likely to be more distinct in the high-risk patients (APACHE II score 24 on day 1 [Fig 1a]), these were chosen as the group of primary interest.
Sample size considerations for nonrandomized ptfmparative studies were done according to Makuch and Simonm;xj/for a power of 0.8 and significance of 0.05. Accordingly, for the higfl-risk group (control response rate: 19 percent), 26 treated patients were required to document an Ig therapy response rate of 50 percent. After having attained this number for the IgG treatment, IgGMA was administered. This study was discontinued after inclusion of 13 high-risk patients given IgGMA (total: 25), since interim analysis revealed that the difference in response rate vs controls had already reached statistical significance (Fig 2). buy antibiotics online

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Early Sepsis Treatment With Immunoglobulins After Cardiac Surgery in Score-identified High-risk Patients – Methods

Early Sepsis Treatment With Immunoglobulins After Cardiac Surgery in Score-identified High-risk Patients - MethodsIn patients after cardiac surgery, the incidence of infections is high, due to cardiac impairment and the intraoperative use of extracoqioreal circulation and its sequelae. Accordingly, sepsis and septic multiple organ failure are among the major causes of death.
Using the APACHE II scores for assessment of disease severity, we have shown that failure to improve promptly after heart surgery (criterion: score 19 on the first postoperative day) was highly predictive for septic complications, associated with a significantly higher mortality. On 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 by more than 50 percent. Using this score in the present study, we (1) prospectively identified postoperative cardiac surgical patients at risk and (2) investigated whether early supplemental sepsis treatment led to an improvement in disease severity and outcome, compared with a matching historical control population. As supplemental sepsis treatment, we used intravenous (IV) immunoglobulin (Ig), which has been shown to reduce infections after cardiac surgery when given prophy-lactically. canadian neighbor pharmacy

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