Prospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Crit Care Med. Jan 9, 2021; 10(1): 22-34
Published online Jan 9, 2021. doi: 10.5492/wjccm.v10.i1.22
Multicentered prospective investigator initiated study to evaluate the clinical outcomes with extracorporeal cytokine adsorption device (CytoSorb®) in patients with sepsis and septic shock
Rajib Paul, Prachee Sathe, Senthil Kumar, Shiva Prasad, Ma Aleem, Prashant Sakhalvalkar
Rajib Paul, Ma Aleem, Department of Internal Medicine and Critical Care, Apollo Health City, Hyderabad 500033, India
Prachee Sathe, Prashant Sakhalvalkar, Department of Critical Care Medicine, Ruby Hall Clinic, Pune 411001, India
Senthil Kumar, Department of Critical Care Medicine, Apollo Hospital, Chennai 600006, India
Shiva Prasad, Department of Anesthesiology and Critical Care, Narayana Institute of Cardiac Sciences, Bangaluru 560099, India
Author contributions: Paul R and Sathe P contributed to study design/planning, review of the study protocol, enrollment of study subjects, follow-up and data collection and review of manuscript; Kumar S and Prasad S were involved in study design/planning, review of the study protocol, enrollment of study subjects, follow-up and data collection, review of manuscript, data collection/entry, data analysis/statistics, data interpretation, preparation of manuscript, literature analysis/search and data management; Aleem M and Sakhalvalkar P participated in data collection/entry, data analysis/statistics, data interpretation, preparation of manuscript, literature analysis/search and data management.
Institutional review board statement: This study was reviewed and approved by an institutional ethics committee.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest.
Data sharing statement: There is no additional data available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Rajib Paul, DNB, MD, Doctor, Professor, Department of Internal Medicine and Critical Care, Apollo Health City, Road Number 72, opp, Bharatiya Vidya Bhavan School, Jubilee Hills, Hyderabad 500033, India. rajib.paulcriticalcare@gmail.com
Received: June 2, 2020
Peer-review started: June 2, 2020
First decision: July 4, 2020
Revised: September 3, 2020
Accepted: November 28, 2020
Article in press: November 28, 2020
Published online: January 9, 2021
Processing time: 217 Days and 16.8 Hours
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

Core Tip: This prospective, real time, observational multicenter study was conducted in 45 patients with sepsis and septic shock. Post therapy, 26 patients survived and dose reduction in norepinephrine, epinephrine and vasopressin was 51.4%, 69.4% and 13.9%, respectively. Interleukin-6 level reduction was 52.3%, and platelet count improved significantly to 30.1%. Mean acute physiology and chronic health evaluation and sequential organ failure assessment scores were reduced significantly. Predicted mortality before CytoSorb® therapy was 56.5%, and mortality reduced to 48.8% after CytoSorb® therapy. The survival rate in patients given treatment in < 24 h of intensive care unit admission was 75% and 68% when given within 24-48 h of intensive care unit admission. CytoSorb® therapy was safe and well tolerated with no adverse events reported.