Multicentered prospective investigator initiated study to evaluate the clinical outcomes with extracorporeal cytokine adsorption device (CytoSorb®) in patients with sepsis and septic shock

Abstract

Background: Sepsis is a severe clinical syndrome related to the host response to infection. The severity of infections is due to an activation cascade that will lead to an auto amplifying cytokine production: The cytokine storm. Hemoadsorption by CytoSorb^® therapy is a new technology that helps to address the cytokine storm and to regain control over various inflammatory conditions.

Aim: To evaluate prospectively CytoSorb^® therapy used as an adjunctive therapy along with standard of care in septic patients admitted to intensive care unit (ICU).

Methods: This was a prospective, real time, investigator initiated, observational multicenter study conducted in patients admitted to the ICU with sepsis and septic shock. The improvement of mean arterial pressure and reduction of vasopressor needs were evaluated as primary outcome. The change in laboratory parameters, sepsis scores [acute physiology and chronic health evaluation (APACHE II) and sequential organ failure assessment (SOFA)] and vital parameters were considered as secondary outcome. The outcomes were also evaluated in the survivor and non-survivor group. Descriptive statistics were used; a P value < 0.05 was considered to be statistically significant.

Results: Overall, 45 patients aged ≥ 18 and ≤ 80 years were included; the majority were men (n = 31; 69.0%), with mean age 47.16 ± 14.11 years. Post CytoSorb^® therapy, 26 patients survived and 3 patients were lost to follow-up. In the survivor group, the percentage dose reduction in vasopressor was norepinephrine (51.4%), epinephrine (69.4%) and vasopressin (13.9%). A reduction in interleukin-6 levels (52.3%) was observed in the survivor group. Platelet count improved to 30.1% (P = 0.2938), and total lung capacity count significantly reduced by 33% (P < 0.0001). Serum creatinine and serum lactate were reduced by 33.3% (P = 0.0190) and 39.4% (P = 0.0120), respectively. The mean APACHE II score was 25.46 ± 2.91 and SOFA scores was 12.90 ± 4.02 before initiation of CytoSorb^® therapy, and they were reduced significantly post therapy (APACHE II 20.1 ± 2.47; P < 0.0001 and SOFA 9.04 ± 3.00; P = 0.0003) in the survivor group. The predicted mortality in our patient population before CytoSorb^® therapy was 56.5%, and it was reduced to 48.8% (actual mortality) after CytoSorb^® therapy. We reported 75% survival rate in patients given treatment in < 24 h of ICU admission and 68% survival rates in patients given treatment within 24-48 h of ICU admission. In the survivor group, the average number of days spent in the ICU was 4.44 ± 1.66 d; while in the non-survivor group, the average number of days spent in ICU was 8.5 ± 15.9 d. CytoSorb^® therapy was safe and well tolerated with no adverse events reported.

Conclusion: CytoSorb^® might be an effective adjuvant therapy in stabilizing sepsis and septic shock patients. However, it is advisable to start the therapy at an early stage (preferably within 24 h after onset of septic shock).

Keywords: Acute physiology and chronic health evaluation score; Hemadsorption; Sepsis; Sequential organ failure assessment score; Vasopressor.

Figure 1

Sepsis scores in survivor group (pre and post Cytosorb^® therapy). Significant P values obtained for both acute physiology and chronic health evaluation (P < 0.0001) and sequential organ failure assessment scores (P = 0.0003). APACHE II: acute physiology and chronic health evaluation; SOFA: Sequential organ failure assessment scores.

Figure 2

Predicted mortality vs actual mortality based on acute physiology and chronic health evaluation.

Figure 3

Time of initiation of CytoSorb^® therapy in survivors and non-survivors.