Determination of the Hemoadsorption Impact as Adjunctive Treatment Upon the Support Therapy of COVID-19

NCT04518969 | Completed

• 1 other identifier: BrugmannUH 1066
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A) Comparing the % of change in each clearances of pro-, and anti-inflammatory mediators (cytokine, chemokines and complement) in the COVID-19 patients treated with CytoSorb as compared to the same patient population who do not receive blood purification treatment. B) Testing the Cytokinetic model by measuring cytokines in the blood stream and in the BAL to see if you can create a reverse gradient allowing a massive passage of leucocyte from the blood toward the infected lungs.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• comparing % of change in cytokine's clearances of pro et anti -inflammatory types

  comparing the % of change in cytokine's clearances of pro et anti -inflammatory types, as well chemokines and complement pathway between a control population and a treated population with sorbent technology.

  Day 1 to 5

Secondary Outcomes (5)

• Evaluation of the impact upon the survival rate at 28 and 90 days.

  Day 28 and Day 90

• Chemokine kinetics

  Day 1 to 5

• Cytokine kinetics

  Day 1 to 5

• Complement pathway kinetics

  Day 1 to 5

• PaO2/FiO2 ratio

  Up to 90 days

Study Arms (2)

Control

NO INTERVENTION

Standard medical therapy (ie: control group) : Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology N =12 -Mechanical ventilation, prone position if needed,fluid challenge if needed , vasopressors if needed, inotropic support in needed……

Cytosorb

EXPERIMENTAL

CytoSorb therapy (ie: study group): Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology N =12 -Mechanical ventilation, prone position if needed,fluid challenge if needed , vasopressors if needed, inotropic support in needed…… Plus patients will be on CRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect. First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours. After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist.

Device: CytoSorb

Interventions

CytoSorb DEVICE

CRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect. First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours. After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist.

Also known as: CRRT

Cytosorb

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology-Patient COVID type L (Criteria Gattinoni -CT Scan )

You may not qualify if:

• Patient COVID type H ( Gattinoni's Criteria -CT Scan )
• Patient's refusal or refusal of his legal representative
• HIV + AIDS
• Short life Expectancy
• Patients over 80 years of age.
• Patients under ECMO or ECCO2R
• Immunosuppression (steroids, chemotherapy…)
• Cancer

Sponsors & Collaborators

• Dr David DE BELS: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (12)

• Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.

  PMID: 32204907 BACKGROUND

• Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in intensive care. Lancet Respir Med. 2020 Mar;8(3):240-241. doi: 10.1016/S2213-2600(20)30060-6. Epub 2020 Feb 6. No abstract available.

  PMID: 32035509 BACKGROUND

• Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M. Feasibility study of cytokine removal by hemoadsorption in brain-dead humans. Crit Care Med. 2008 Jan;36(1):268-72. doi: 10.1097/01.CCM.0000291646.34815.BB.

  PMID: 18090355 BACKGROUND

• 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;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.

  PMID: 30448517 BACKGROUND

• Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.

  PMID: 32291463 BACKGROUND

• Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.

  PMID: 12147537 BACKGROUND

• Kellum JA, Kong L, Fink MP, Weissfeld LA, Yealy DM, Pinsky MR, Fine J, Krichevsky A, Delude RL, Angus DC; GenIMS Investigators. Understanding the inflammatory cytokine response in pneumonia and sepsis: results of the Genetic and Inflammatory Markers of Sepsis (GenIMS) Study. Arch Intern Med. 2007 Aug 13-27;167(15):1655-63. doi: 10.1001/archinte.167.15.1655.

  PMID: 17698689 BACKGROUND

• Honore PM, Hoste E, Molnar Z, Jacobs R, Joannes-Boyau O, Malbrain MLNG, Forni LG. Cytokine removal in human septic shock: Where are we and where are we going? Ann Intensive Care. 2019 May 14;9(1):56. doi: 10.1186/s13613-019-0530-y.

  PMID: 31089920 BACKGROUND

• Cavaillon JM, Munoz C, Fitting C, Misset B, Carlet J. Circulating cytokines: the tip of the iceberg? Circ Shock. 1992 Oct;38(2):145-52.

  PMID: 1423923 BACKGROUND

• Akil A, Ziegeler S, Reichelt J, Rehers S, Abdalla O, Semik M, Fischer S. Combined Use of CytoSorb and ECMO in Patients with Severe Pneumogenic Sepsis. Thorac Cardiovasc Surg. 2021 Apr;69(3):246-251. doi: 10.1055/s-0040-1708479. Epub 2020 Apr 6.

  PMID: 32252114 BACKGROUND

• Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.

  PMID: 30301856 BACKGROUND

• Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmele T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis. Kidney Int. 2012 Feb;81(4):363-9. doi: 10.1038/ki.2011.320. Epub 2011 Sep 14.

  PMID: 21918497 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Patrick Honore, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairmn ICU

Model Details: Pilot randomized controlled study

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: August 19, 2020
• Study Start: May 3, 2020
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)