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

Differences between groups were statistically analyzed using the.V“ test with Yates’ correction for categorical variables; for continuous variables, the Student’s t test for unpaired data or the Mann-Whitnev V test was used, where appropriate. Changes of values within groups were analyzed using Scheffe’s multiple range test. A p value of <0.05 was considered statistically significant. All values are given as mean±95 percent confidence interval for the mean. Among 881 control patients (Table 1), three risk categories could be clearly identified (p<0.0001) by the APACHE II score on the first day after cardiac surgery (Fig 1a): 95.2 percent with a score <19 have a low risk (1 percent as previously reported); patients with a score of 19 to 23 (2.4 percent) have a considerably increased risk of postsurgical complications (mainly due to sepsis mortality: 14 percent); patients with an APACHE II score 24 (2.4 percent) have the highest risk (mortality: 76 percent).

Table 1—Baseline Characteristics of Patients According to Treatment Group

Parameter Control (n = 42) IgG (n = 41) Pt IgGMA(n = 25) Pt
Postoperative risk profile (day 1)
Total postoperative patients 881 789 552
eligible for scoring (see “Methods”)
Postoperative risk patients 42 (4.8%) 41 (5.2%) NS 25 (4.5%) NS
(APACHE 11 score: >19)
Postoperative high-risk patients 21 (2.4%) 26 (3.3%) NS 13 (2.4%) NS
(APACHE II score: >24)
Demographic data$
Age, yr 65.0 (62.8-67.2) 65.9 (63.4-68.4) NS 66.6 (62.7-70.5) NS
Sex, M/F 29/13 25/16 NS 17/8 NS
Operation $
ECC (min) 103 (91-115) 121 (104-138) NS 109 (93-125) NS
% valve surgery 45% 39% NS 52% NS
Pretreatment disease severity!
APACHE II score 24.2 (22.9-25.5) 26.5 (24.4-28.6) NS 26.8 (22.6-27.0) NS
Elebute sepsis score 12.6 (11.6-13.6) 13.2 (12.0-14.4) NS 12.1 (11.1-13.1) NS
Positive sepsis criteria 5.0 (4.7-5.3) 5.1 (4.7-5.5) NS 5.2 (4.7-5.7) NS
Glasgow Coma Scale 8.5 (7.6-9.4) 8.3 (7.4-9.2) NS 8.3 (7.0-9.6) NS
SVR, dyne*cm ‘‘•s 932 (798-1066) 806 (699-913) NS 836 (553-1119) NS
Cl, iymin/m2 3.1 (2.6-3.6) 3.4 (2.9-3.9) NS 3.2 (2.7-3.7) NS
MAP, mm Hg 75 (67-83) 69 (63-75) NS 67 (56-78) NS
Heart rate, /min 111 (105-117) 120 (113-127) NS 120 (103-137) NS
P(A-a)Oz, mm Hg 283 (244-322) 263 (225-301) NS 274 (204-344) NS
Serum creatinine, mg/dl 2.1 (1.8-2.4) 1.9 (1.7-2.1) NS 1.8 (1.5-2.1) NS
Serum bilirubin, mg/dl 3.0 (2.2-3.8) 3.1 (2.2-4.0) NS 4.1 (2.2-6.0) NS
Serum albumin, g^dl 3.9 (3.6-4.2) 4.2 (3.9-4.5) NS 4.5 (4.2-4.8) <0.001
Prothrombin time, % 53 (47-59) 54 (49-59) NS 58 (53-63) NS
Thrombocytes, G/L 116 (94-138) 113 (93-133) NS 132 (106-158) NS
Leukocytes, G/L 10.2 (9.0-11.4) 13.0 (11.3-14.7) <0.001 11.9 (10.1-13.7) NS
Temperature, °C 38.5 (38.1-38.9) 38.2 (37.6-38.8) NS 37.5 (36.9-38.1) <0.01
Antibiotic therapy!
Antibiotics on day 1 (No.) 1.1 (0.8-1.4) 1.5 (1.1-1.9) NS 1.9 (1.3-2.5) <0.05
Antibiotics on day 3 (No.) 1.6 (1.2-2.0) 1.9 (1.6-2.2) NS 2.2 (1.7-2.7) <0.05

Table 2—Prognostic Implication of the APACHE 11 Score Criterion for “Response to Therapy ” m Patients After Cardiac Surgery

Therapy Mortality (%) P
Responders Nonresponders
Standard (controls) 1/15 (7) 18/27 (67) <0.001
IgG 2/22 (9) 11/19 (58) <0.005
IgGMA 1/14 (7) 7/11 (64) <0.01

Figure-2

Figure 2. Response and mortality rates according to therapy. Upper panel: high-risk group. Lower panel: total (risk plus high-risk) study population.

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