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)