46 N . Jabayeva et al .: J Extra Corpor Technol 2024 , 56 , 45 – 54
Table 1 . Patients characteristics .
Characteristics |
HA 330 group ( n = 20 ) |
CytoSorb 300 group ( n = 20 ) |
Control group ( n = 20 ) |
P value |
Demography Mean age ( years ) |
53.19 ± 14.44 |
49.15 ± 18.15 |
51.68 ± 12.58 |
0.26 |
Male , n (%) |
9 ( 45 %) |
11 ( 55 %) |
13 ( 65 %) |
|
Female , n (%) |
11 ( 55 %) |
9 ( 45 %) |
7 ( 35 %) |
|
Comorbidity , mean ± SD BMI |
26.58 ± 4.46 |
26.94 ± 3.7 |
28.18 ± 5.8 |
0.14 |
Apache II score , points |
16.73 ± 2.55 |
14.32 ± 6.25 |
12.73 ± 8.29 |
0.10 |
Diabetes requiring insulin |
2 ( 10 %) |
1 ( 5 %) |
1 ( 5 %) |
|
Ischemic stroke |
1 ( 5 %) |
1 ( 5 %) |
1 ( 5 %) |
|
Cardiac surgery Heart valve surgery , n (%) |
10 ( 50 %) |
11 ( 55 %) |
9 ( 45 %) |
|
GABG , n (%) |
1 ( 5 %) |
1 ( 5 %) |
3 ( 15 %) |
|
Surgery on aorta , n (%) |
7 ( 35 %) |
4 ( 20 %) |
7 ( 35 %) |
|
Heart transplantation |
2 ( 10 %) |
1 ( 5 %) |
0 |
|
LVAD |
0 |
3 ( 15 %) |
1 ( 5 %) |
|
Reoperation |
6 ( 30 %) |
2 ( 10 %) |
2 ( 10 %) |
|
Emergency surgery |
1 ( 5 %) |
3 ( 15 %) |
2 ( 10 %) |
|
Cardiogenic shock |
1 ( 5 %) |
1 ( 5 %) |
0 |
|
CPB time ( min ) |
218.14 ± 86.92 |
201.85 ± 65.39 |
194.45 ± 42.42 |
0.5 |
Cross clamp time ( min ) |
121.23 ± 66.91 |
103.25 ± 56.86 |
115 ± 44.69 |
0.5 |
Circulatory arrest ( min ) |
4.04 ± 8.08 |
8.45 ± 9.47 |
3.5 ± 8.31 |
0.14 |
patient after the surgery . In fact , the systemic inflammatory background is exacerbated by massive therapeutic invasion , surgical trauma , CPB [ 6 ], and blood product transfusion [ 14 ]. Heart surgery and CPB invariably cause systemic inflammatory response syndrome . Release of many cytokines , including IL-1 , IL-6 , IL-8 , IL 10 , complement C3 / C4 , and tumor necrosis factor-a PCT , Leucocytes are characteristic of the inflammation and contribute to postoperative acute kidney injury ( AKI ) [ 6 ].
For the diagnosis of cardiac surgery-associated acute kidney injury ( CSA-AKI ) the Kidney Disease Improving Global Outcomes ( KDIGO ) classification has become a consensus with greater sensitivity in the detection of AKI postoperatively than other classifications [ 6 ].
We conducted this study to compare levels of inflammatory markers and the incidence of CSA-AKI in the early postoperative period after prolonged CPB using CytoSorb-300 and HA-330 .
Materials and methods
We conducted a retrospective review of prospectively collected data in a single tertiary care center between January 2021 and May 2022 . The study was approved by the Local Bioethics Committee ( No . 01-74 / 2021 from 10 / 06 / 20 ), and registered in ClinicalTrials . gov PRS , Protocol registration and results system ( NCT05090930 ). Two types of HA devices were used – Jafron HA 330 ( HA 330 , Jafron Biomedical Co ., Ltd . China ) and CytoSorb 300 ( CytoSorb Ò , cartridge , Cytosorbents Europe GmbH , Germany ) ( see Supplementary table for characteristics of the adsorbent cartridges ). Sixty patients with a CPB ( LivaNova Sorin Stockert S5 , Germany , tubing pack , and oxygenator Inspire8 with an integrated filter Livanova , Affinity Fusion Medtronic , Alone Eurosets ) duration exceeding 120 min . formed the study group . The mean age of the patients was 53
(± 14 ) years in the HA 330 group vs . 49 (± 18 ) years in the CytoSorb 300 group and 51 (± 12 ) years in the control group , with 45 %, 55 %, and 65 % of patients being male respectively . The mean body mass index ( BMI ) and Apache II score were similar in all groups . The baseline parameters and surgery characteristics are presented in Table 1 .
At the time of analysis for this article , 40 patients had cytokine adsorption and 20 patients without adsorption while on prolonged CPB scheduled for elective complex cardiac surgery with CPB duration > 120 min . All patients were intraoperatively single randomized by 1:1:1 into three study groups : Cytosorb , CS ( n = 20 ; installed in the CPB circuit ), Jafron HA , JHA ( n = 20 ; installed in the CPB circuit ) and Control , CO ( n = 20 , usual care , neither Cytosorb nor Jafron during CPB ). The primary outcomes of the study were the postoperative level of inflammatory markers ( IL-1 , 6 , 8 ; CRP , Leukocyte , Lactate , PCT , NT-proBNP , TNF-a ), and incidence of acute kidney injury by KDIGO classification . Secondary outcomes of interest were duration of mechanical ventilation , length of ICU and hospital stay , and hospital mortality . Each patient received three consecutive HA procedures , ( the first procedure intraoperatively during CPB , and two consecutive procedures in the postoperative period ).
Preparatory washing of the adsorbents and heparinization during the procedures was carried out according to the manufacturer ’ s instructions . Anticoagulation was achieved by administering heparin ( individual dosage , according to the laboratory data and the condition of the post-operative bleeding ). All adsorption procedures were performed in a standard manner in HA 330 and Cytosorb groups . The first HA procedure was initiated intraoperatively from the start of the CPB . The second HA procedure was conducted in the early postoperative period in the ICU 6 h after surgery . The third HA procedure was conducted consecutively after the end of the second procedure . In all cases , the cartridges were incorporated into a