48 N . Jabayeva et al .: J Extra Corpor Technol 2024 , 56 , 45 – 54
Table 2 . Secondary outcomes .
Mean ± standard deviation |
HA 330 group ( n = 20 ) |
CytoSorb300 group ( n = 20 ) |
Control group ( n = 20 ) |
P value |
ICU stay ( days ) |
3.80 ± 7.24 |
4.47 ± 5.58 |
10.05 ± 17.52 |
0.08 |
Mechanical ventilation ( days ) |
3.33 ± 5.24 |
3.42 ± 5.51 |
7.7 ± 17.39 |
0.17 |
Hospital stay ( days ) |
24.05 ± 12.24 |
23.31 ± 14.38 |
28.63 ± 18.39 |
0.47 |
Mortality |
1 ( 5 %) |
1 ( 5 %) |
2 ( 10 %) |
|
The duration of HA with the CytoSorb 300 cartridge was 24 h and with the HA 330 cartridge – 6 h according to the manufacturer ’ s recommendations .
Data collection
Trends of inflammatory markers ( IL-6 , IL-8 , IL-10 , TNF-a , CRP , Leukocytes , Lactate , PCT , NT-proBNP , urea , creatinine ) were assessed . Blood samples were collected seven times : the – first before surgery , the – second 1 hour on CPB , the third – at the end of CPB , the fourth – 2 h after surgery , the fifth – 6 h after surgery , the sixth – 12 h after surgery and the seventh – 24 h after surgery .
The APACHE II score was used to assess patients 6 h after ICU admission following surgery .
Ethical statement
The study was approved by the Local Bioethics Committee of the National Research Cardiac Surgery Center ( No . 01-74 / 2021 from 10 / 06 / 20 ), and registered in ClinicalTrials . gov Protocol and Outcome Registration System ( NCT05042622 ). All patients ’ personal information was coded and data were anonymized at the time of data collection to protect patients ’ rights and not to divulge their personal information . The researchers received an electronic database with only patient demographic and clinical information , which was analyzed and presented only in aggregate form , further guaranteeing data confidentiality .
Statistical analysis
Statistical analyses were performed using SPSS ( version 26 IBM , SPSS Inc ., Chicago , IL , USA ). Demographic and clinical baseline data are presented as mean and standard deviation , expressed through minimum and maximum , for metric variables or absolute frequencies for categorical variables . Differences between groups were analyzed by using the analysis of variance ( ANOVA ) test for to compare the means of two or more independent samples . A significant difference was assumed for p-values less than 0.05 . Results are presented as medians with interquartile ranges .
Results
Intraoperative parameters were comparable between the groups . The mean CPB time was 218 (± 86 ) min in the HA 330 group versus 201 (± 65 ) min in the CytoSorb 300 group , and 194 (± 42 ) min in the control group .
The mean duration of postoperative mechanical ventilation was 3.33 ± 5.24 days versus 3.42 ± 5.5 days versus 7.7 ± 17.39 days in HA330 , Cytosorb , and control group respectively .
The duration of stay in the ICU ( 3.8 ± 7.24 vs . 4.47 ± 5.58 vs . 10 ± 17.52 days , respectively ) was not significantly shorter in the HA330 group ( p = 0.08 ).
Mortality was observed in all groups . There was one death in the HA-330 group , one death in the CytoSorb-300 group , and two deaths in the control group ( Table 2 ).
All patients had elevated inflammatory markers in the perioperative and postoperative periods . After 24 h of intensive therapy , inflammatory markers in the blood tended to decrease in all three groups ( Figure 2 ). The laboratory data of HA330 , CytoSorb 300 , and control groups are shown in Figures 2 and 3 . In our study , we found that the use of blood purification adsorbers during and after surgery with cardiopulmonary bypass was associated with a reduction of IL-6 , CRP , and leucocytes . Patients in both HA groups demonstrated some different values of inflammatory markers throughout the first three days . For HA 330 there was a gradual decrease of IL 6 , IL 8 , and IL 10 after peak on the first day . Cytosorb cartridge showed a more prominent and stable decrease of IL 1 b , IL6 , andIL8 throw-out implementation period of adsorption . Preoperative NT Pro-BNP levels were higher in the HA group . This could be explained by advanced heart failure in patients with multivalvular disease , redo surgery , and shock conditions that consisted HA group . After surgery , Pro-BNP levels increased more prominent in the control group indicating the possible influence of sorbents .
In the postoperative period , acute kidney injury was diagnosed in 17 patients ( 28.3 %). Of these , seven patients were in the Jafron HA 330 , two in the CytoSorb300 , and eight in the control group . Severe early ischemic liver injury after cardiac surgery occurred in one patient in the Jafron HA 330 group , one in the CytoSorb300 group , and three patients in the control . Cardiac or respiratory failure requiring support with V-A ECMO was necessary in five patients in the Jafron HA 330 group , four in the CytoSorb-300 group , and in two patients in the control group . Increased pericardial bleeding as per Kirklin criteria of more than 500 ml during the first hours was found in the Jafron HA 330 group in three patients , as well as one in each of the CytoSorb 300 and control groups . Heparin-induced thrombocytopenia was laboratory and clinically diagnosed by one patient in the HA 330 and control groups . One patient in the group receiving CytoSorb300 had an ischemic stroke , see Table 3 . Extracorporeal blood purification procedures in groups was shown on Table 4 . Discussion
Excessively high levels of inflammatory mediators are common during critical illness and might be associated with adverse outcomes . The extracorporeal blood purification