Effect of Hemadsorption Therapy in Critically Ill Patients with COVID-19 (CYTOCOV-19): A Prospective Randomized Controlled Pilot Trial

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Article / Publication Details

First-Page Preview

Abstract of Critical Care Nephrology – Research Article

Received: December 30, 2021
Accepted: June 27, 2022
Published online: September 08, 2022

Number of Print Pages: 10
Number of Figures: 2
Number of Tables: 3

ISSN: 0253-5068 (Print)
eISSN: 1421-9735 (Online)

For additional information: https://www.karger.com/BPU

Abstract

Introduction: Immunomodulatory therapies have shown beneficial effects in patients with severe COVID-19. Patients with hypercytokinemia might benefit from the removal of inflammatory mediators via hemadsorption. Methods: Single-center prospective randomized trial at the University Medical Center Hamburg-Eppendorf (Germany). Patients with confirmed COVID-19, refractory shock (norepinephrine ≥0.2 µg/kg/min to maintain a mean arterial pressure ≥65 mm Hg), interleukin-6 (IL-6) ≥500 ng/L, and an indication for renal replacement therapy or extracorporeal membrane oxygenation were included. Patients received either hemadsorption therapy (HT) or standard medical therapy (SMT). For HT, a CytoSorb® adsorber was used for up to 5 days and was replaced every 18–24 h. The primary endpoint was sustained hemodynamic improvement (norepinephrine ≤0.05 µg/kg/min ≥24 h). Results: Of 242 screened patients, 24 were randomized and assigned to either HT (N = 12) or SMT (N = 12). Both groups had similar severity as assessed by SAPS II (median 75 points HT group vs. 79 SMT group, p = 0.590) and SOFA (17 vs. 16, p = 0.551). Median IL-6 levels were 2,269 (IQR 948–3,679) and 3,747 (1,301–5,415) ng/L in the HT and SMT groups at baseline, respectively (p = 0.378). Shock resolution (primary endpoint) was reached in 33% (4/12) versus 17% (2/12) in the HT and SMT groups, respectively (p = 0.640). Twenty-eight-day mortality was 58% (7/12) in the HT compared to 67% (8/12) in the SMT group (p = 1.0). During the treatment period of 5 days, 6/12 (50%) of the SMT patients died, in contrast to 1/12 (8%) in the HT group. Conclusion: HT was associated with a non-significant trend toward clinical improvement within the intervention period. In selected patients, HT might be an option for stabilization before transfer and further therapeutic decisions. This finding warrants further investigation in larger trials.

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References Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, et al. Baseline characteristics and outcomes of 1,591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy region, Italy. JAMA. 2020 Apr 6;323(16):1574–81. Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA. 2020 May 26;323(20):2052–9. WHO. World Map: COVID-19. 2021. Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical characteristics of Coronavirus disease 2019 in China. N Engl J Med. 2020;382(18):1708–20. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. Roedl K, Jarczak D, Thasler L, Bachmann M, Schulte F, Bein B, et al. Mechanical ventilation and mortality among 223 critically ill patients with COVID-19: a multicentric study in Germany. Aust Crit Care. 2021;32(2):167–75. Karagiannidis C, Mostert C, Hentschker C, Voshaar T, Malzahn J, Schillinger G, et al. Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study. Lancet Respir Med. 2020;8(9):853–62. Richards-Belle A, Orzechowska I, Gould DW, Thomas K, Doidge JC, Mouncey PR, et al. COVID-19 in critical care: epidemiology of the first epidemic wave across England, Wales and Northern Ireland. Intensive Care Med. 2020;46(11):2035–47. COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60–73. McElvaney OJ, McEvoy NL, McElvaney OF, Carroll TP, Murphy MP, Dunlea DM, et al. Characterization of the inflammatory response to severe COVID-19 illness. Am J Respir Crit Care Med. 2020 Sep 15;202(6):812–21. Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033–4. Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Mar 3;46(5):846–8. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054–62. Kaur S, Bansal R, Kollimuttathuillam S, Gowda AM, Singh B, Mehta D, et al. The looming storm: blood and cytokines in COVID-19. Blood Rev. 2021 Mar;46:100743. Gustine JN, Jones D. Immunopathology of hyperinflammation in COVID-19. Am J Pathol. 2021 Jan;191(1):4–17. Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, et al. Dexamethasone in hospitalized patients with COVID-19: preliminary report. N Engl J Med. 2021;384(8):693–704. Salama C, Han J, Yau L, Reiss WG, Kramer B, Neidhart JD, et al. Tocilizumab in patients hospitalized with Covid-19 pneumonia. N Engl J Med. 2021;384(1):20–30. Hermine O, Mariette X, Tharaux P-L, Resche-Rigon M, Porcher R, Ravaud P, et al. Effect of tocilizumab vs usual care in adults hospitalized with covid-19 and moderate or severe pneumonia: a randomized clinical trial. JAMA Inter Med. 2021;181(1):32–40. Tay MZ, Poh CM, Rénia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363–74. Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252–9. Poli EC, Rimmelé T, Schneider AG. Hemoadsorption with CytoSorb(®). Intensive Care Med. 2019 Feb;45(2):236–9. Kogelmann K, Jarczak D, Scheller M, Druner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. Kogelmann K, Scheller M, Drüner M, Jarczak D. Use of hemoadsorption in sepsis-associated ECMO-dependent severe ARDS: a case series. J Intensive Care Soc. 2020 May;21(2):183–90. FDA. CytoSorb® emergency use authorization for use in patients with COVID-19 infection. 2020. Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, et al. Acute respiratory distress syndrome: the Berlin definition. JAMA. 2012 Jun 20;307(23):2526–33. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22–29;270(24):2957–63. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the working group on sepsis-related problems of the european society of intensive care medicine. Intensive Care Med. 1996 Jul;22(7):707–10. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–83. Alhazzani W, Møller MH, Arabi YM, Loeb M, Gong MN, Fan E, et al. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854–87. Kluge S, Janssens U, Welte T, Weber-Carstens S, Marx G, Karagiannidis C. German recommendations for critically ill patients with COVID-19. Med Klin Intensivmed Notfmed. 2020 Dec;115(Suppl 3):111–4. Alhazzani W, Evans L, Alshamsi F, Møller MH, Ostermann M, Prescott HC, et al. surviving sepsis campaign guidelines on the management of adults with coronavirus disease 2019 (COVID-19) in the ICU: first update. Crit Care Med. 2021 Mar 1;49(3):e219–34. RENAL Replacement Therapy Study Investigators; Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, et al. Intensity of continuous renal-replacement therapy in critically ill patients. N Engl J Med. 2009;361(17):1627–38. Joannidis M, John S. Acute kidney injury and renal replacement therapy in critically ill patients in 2018: recommendations from the renal section of the DGIIN, ÖGIAIN and DIVI. Med Klin Intensivmed Notfmed. 2018 Jun;113(5):356–7. Dupont T, Caillat-Zucman S, Fremeaux-Bacchi V, Morin F, Lengliné E, Darmon M, et al. Identification of distinct immunophenotypes in critically ill coronavirus disease 2019 patients. Chest. 2021 May;159(5):1884–93. Villa G, Romagnoli S, De Rosa S, Greco M, Resta M, Pomarè Montin D, et al. Blood purification therapy with a hemodiafilter featuring enhanced adsorptive properties for cytokine removal in patients presenting COVID-19: a pilot study. Crit Care. 2020 Oct 12;24(1):605. Alharthy A, Faqihi F, Memish ZA, Balhamar A, Nasim N, Shahzad A, et al. Continuous renal replacement therapy with the addition of CytoSorb cartridge in critically ill patients with COVID-19 plus acute kidney injury: a case-series. Artif Organs. 2021 May;45(5):E101–12. Kox M, Waalders NJB, Kooistra EJ, Gerretsen J, Pickkers P. Cytokine levels in critically ill patients with COVID-19 and other conditions. JAMA. 2020 Sep 3;324(15):1565–7. Sinha P, Calfee CS, Cherian S, Brealey D, Cutler S, King C, et al. Prevalence of phenotypes of acute respiratory distress syndrome in critically ill patients with COVID-19: a prospective observational study. Lancet Respir Med. 2020 Dec;8(12):1209–18. Supady A, Weber E, Rieder M, Lother A, Niklaus T, Zahn T, et al. Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation (CYCOV): a single centre, open-label, randomised, controlled trial. Lancet Respir Med. 2021 Jul;9(7):755–62. Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: a proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172–8. Schädler D, Pausch C, Heise D, Meier-Hellmann A, Brederlau J, Weiler N, et al. The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: a randomized controlled trial. PLoS One. 2017;12(10):e0187015. Lebreton G, Dorgham K, Quentric P, Combes A, Gorochov G, Schmidt M. Longitudinal Cytokine Profiling in Patients with Severe COVID-19 on Extracorporeal Membrane Oxygenation and Hemoadsorption. Am J Respir Crit Care Med. 2021 Jun 1;203(11):1433–5. Scharf C, Schroeder I, Paal M, Winkels M, Irlbeck M, Zoller M, et al. Can the cytokine adsorber CytoSorb® help to mitigate cytokine storm and reduce mortality in critically ill patients? A propensity score matching analysis. Ann Intensive Care. 2021 Jul 22;11(1):115. Jarczak D, Roedl K, Fischer M, de Heer G, Burdelski C, Frings DP, et al. Effect of hemadsorption therapy in critically ill patients with COVID-19 (CYTOCOV-19): a prospective randomized controlled pilot trial, version 1 [Preprint]. Research Square; 2021. Article / Publication Details

First-Page Preview

Abstract of Critical Care Nephrology – Research Article

Received: December 30, 2021
Accepted: June 27, 2022
Published online: September 08, 2022

Number of Print Pages: 10
Number of Figures: 2
Number of Tables: 3

ISSN: 0253-5068 (Print)
eISSN: 1421-9735 (Online)

For additional information: https://www.karger.com/BPU

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