RESULTS
Regarding demographics, 45 males (56.3%) and 35 females (43.8%) were enrolled. The mean age of all enrolled patients was 49.9 ± 12.884 years. There were no statistically significant differences between the two groups in their sex (p= 0.652) or age (p= 0.062). The most prevalent causes of admission of all patients were hepatic causes (25%) such as hepatic encephalopathy, ascites, and variceal bleeding. This prevalence of hepatic patients is explained as one of enrollment centers is a hepatology center. All other causes were distributed similarly across the two studied groups without statistically significant differences (p>0.05). (Table 1)
The most prevalent medical history was obstructive lung diseases (40%), followed be smoking (35%), atrial fibrillation (33.8%), and hypertension (30%). All medical and drug histories were equally distributed across the 2 groups except diabetes, it was more prevalent in ASTRALI group (45%) than control group (20%) (p= 0.031). The mean APACHE II score was 19.9 ±7.653. The mean SOFA score was 6.3 ± 2.867. Regarding Child Pugh score, most of the enrolled patients were classified as class A (75%). All clinical scores were comparable across the 2 groups (p>0.05). (Table 1)
Regarding the measured primary outcomes of ASTRALI group before (T0) and after treatment (T96), ASTRALI group showed statistically significant reduction of median CRP levels (68 ± 55 Vs. 189.8 ± 96 mg/L,p <0.0001), median IL-8 levels (11.8 ± 7.3 Vs.38.1 ± 17.624 pg/L,p <0.0001), and median MDA levels (0.197 ± 0.034 Vs. 0.280 ± 0.0553 µM/L) (p< 0.0001). ASTRALI group showed statistically significant elevations of median IL-10 (31.6 ± 25.8 Vs. 14.1 ± 5.411 pg/mL, p< 0.0001), median SOD levels (12876 ± 4627 Vs. 8493 ± 4489 U/L, p< 0.0001), and median VC levels (130.5 ± 111.65 Vs. 3.4 ± 2.00 mg/L,p= 0.005). ASTRALI group showed comparable median IL-1β levels (11.7 ± 5.338 Vs. 12.4 ± 4.835 mg/L, p= 0.098). (Table 2, Figure 2)
Regarding secondary outcomes, ASTRALI group showed significantly higher median of P/F ratios (342 ± 39) than control group (234 ± 57) at T96 (p <0.0001). (Table 2, Figure 3) ASTRALI group showed significantly lower 7-days mortality rate (15%) than control group (42.5%) (p= 0.013). After multivariate logistic regression, ASTRALI group was associated with significant 75.7% reduction of 7-days mortality (OR=0.243 [95% CI: 0.082 – 0.721], p= 0.011). (Table 3) Both groups showed comparable 28-days mortality rate without statistically significant differences (p= 0.173). (Figure 4)