Septic Shock Clinical Trial
Official title:
Cytokine Adsorption in Severe, Refractory Septic Shock
Verified date | June 2021 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Septic shock and the underlying dysregulated inflammatory host-response remain a major contributor to mortality in critically ill patients. Cytokine adsorption represents an attractive approach to the treatment of septic shock. Nevertheless, its effect on circulating cytokine levels, as well as on the course of disease remains largely unassessed.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 31, 2018 |
Est. primary completion date | August 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients diagnosed septic shock in the 24 hours ensuing diagnosis: (I) severe, refractory septic shock defined as: 1. an acute SOFA score increase =2 points consequent to a presumed or proven infection 2. volume resuscitation of at least 30ml/kg in the last 24 hours 3. a Vasopressor Dependency Index11 (VPI) above or equal to 3 4. a persistently elevated serum lactate level >2mmol/l (II) Interleukin-6 levels equal or above 1000 ng/l (III) were above 18 years of age. Exclusion Criteria: 1. Contraindication on ethical grounds 2. child bearing or breastfeeding women 3. terminal patients 4. human immunodeficiency virus with a CD4 cell count <0.2 106/l 5. allergy to Polystyrene/ Divinylbenzene, Polycarbonate, Polypropylene, Silicon or Polyester 6. need for extra-corporeal membrane oxygenation 7. no given consent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Zurich | CytoSorbents Europe GmbH |
D Schädler, C Porzelius, A Jörres, G Marx, A Meier-Hellmann, C Putensen, M Quintel, C Spies, C Engel, NWeiler, M Kuhlmann. A multicenter randomized controlled study of an extracorporeal cytokine hemoadsorption device in septic patients. Critical Care 2013, 17(Suppl 2):P62 (19 March 2013).
Kellum JA, Song M, Venkataraman R. Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-kappaB DNA binding, and improves short-term survival in lethal endotoxemia. Crit Care Med. 2004 Mar;32(3):801-5. — View Citation
Morris C, Gray L, Giovannelli M. Early report: The use of Cytosorb™ haemabsorption column as an adjunct in managing severe sepsis: initial experiences, review and recommendations. J Intensive Care Soc. 2015 Aug;16(3):257-264. doi: 10.1177/1751143715574855. Epub 2015 Mar 18. — View Citation
Peng ZY, Carter MJ, Kellum JA. Effects of hemoadsorption on cytokine removal and short-term survival in septic rats. Crit Care Med. 2008 May;36(5):1573-7. doi: 10.1097/CCM.0b013e318170b9a7. — View Citation
Reiter K, Bordoni V, Dall'Olio G, Ricatti MG, Soli M, Ruperti S, Soffiati G, Galloni E, D'Intini V, Bellomo R, Ronco C. In vitro removal of therapeutic drugs with a novel adsorbent system. Blood Purif. 2002;20(4):380-8. — View Citation
Rimmelé T, Kellum JA. Clinical review: blood purification for sepsis. Crit Care. 2011;15(1):205. doi: 10.1186/cc9411. Epub 2011 Feb 16. Review. — View Citation
Taniguchi T. Cytokine adsorbing columns. Contrib Nephrol. 2010;166:134-141. doi: 10.1159/000314863. Epub 2010 May 7. — View Citation
Wang H, Ma S. The cytokine storm and factors determining the sequence and severity of organ dysfunction in multiple organ dysfunction syndrome. Am J Emerg Med. 2008 Jul;26(6):711-5. doi: 10.1016/j.ajem.2007.10.031. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in circulating Interleukin-6 levels over time | Change in circulating Interleukin-6 levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Primary | Change in Vasopressor requirements over time | Change in the Vasopressor Dependency Index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours | |
Primary | Cumulative intensive care mortality at 30 days | Intensive care mortality assessment at day 30 between groups | 30 days post fulfillment of inclusion criteria | |
Secondary | Change in C-reactive protein levels over time | Change in C-reactive protein levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Secondary | Change in Procalcitonin levels over time | Change in Procalcitonin levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Secondary | Change in SOFA Score over time | Change in SOFA Score, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Secondary | Change in arterial lactate levels over time | Change in arterial lactate levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours | |
Secondary | Change in cardiac index over time | Change in cardiac index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours | |
Secondary | Change in Extra Vascular Lung Water Index over time | Change in Extra Vascular Lung Water Index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Secondary | Change in daily Infused Volume over time | Change in daily Infused Volume, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Secondary | Change in PaO2/ FiO2 Ratio over time | Change in PaO2/ FiO2 Ratio, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours | |
Secondary | Change in Serum Albumin levels over time | Change in Serum Albumin levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours | |
Secondary | Change in Bilirubin levels over time | Change in Bilirubin levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria | Mixed Model Assessment at timepoints 0, 24, 48, 72 hours |
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