Adjuvant Therapy With CytoSorb in Refractory Septic Shock
ACYSS
Effect of the CytoSorb Adsorber on Hemodynamic, Immunological and Pharmacokinetic Parameters in Refractory Septic Shock
2 other identifiers
interventional
32
1 country
1
Brief Summary
This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 8, 2022
November 1, 2022
3.9 years
June 15, 2019
November 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment
Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.
48 hours
Secondary Outcomes (15)
Change in organ dysfunction
10 days
Lactate clearance
10 days
Renal replacement therapy
10 days
Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 24 hours of treatment
24 hours
End of septic shock
10 days
- +10 more secondary outcomes
Study Arms (2)
CytoSorb-Therapy
ACTIVE COMPARATORTherapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy in combination with haemadsorption using CytoSorb-Adsorber
Standard of care
NO INTERVENTIONTherapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy
Interventions
Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy
Eligibility Criteria
You may qualify if:
- Refractory septic shock
- Need for Norepinephrine ≥ 0.25 µg/kg/min
- IL6 ≥ 1000 ng/l
- Indication for CRRT
You may not qualify if:
- Sepsis due to pulmonary or urogenital causes
- Onset of septic shock longer than 36 hours
- Liver cirrhosis Child Pugh C
- "do not resuscitate"-order
- expected survival \< 14 days
- participation in another interventional trial
- Pregnancy or breastfeeding
- Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- CytoSorbents, Inccollaborator
Study Sites (1)
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Related Publications (5)
Taeb AM, Hooper MH, Marik PE. Sepsis: Current Definition, Pathophysiology, Diagnosis, and Management. Nutr Clin Pract. 2017 Jun;32(3):296-308. doi: 10.1177/0884533617695243. Epub 2017 Mar 17.
PMID: 28537517BACKGROUNDFriesecke 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):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.
PMID: 28589286BACKGROUNDGarau I, Marz A, Sehner S, Reuter DA, Reichenspurner H, Zollner C, Kubitz JC. Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor alpha serum levels in cardiac surgery: a randomized controlled trial. Minerva Anestesiol. 2019 Jul;85(7):715-723. doi: 10.23736/S0375-9393.18.12898-7. Epub 2018 Nov 22.
PMID: 30481999BACKGROUNDKogelmann K, Jarczak D, Scheller M, Druner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. doi: 10.1186/s13054-017-1662-9.
PMID: 28343448BACKGROUNDBayer O, Reinhart K, Kohl M, Kabisch B, Marshall J, Sakr Y, Bauer M, Hartog C, Schwarzkopf D, Riedemann N. Effects of fluid resuscitation with synthetic colloids or crystalloids alone on shock reversal, fluid balance, and patient outcomes in patients with severe sepsis: a prospective sequential analysis. Crit Care Med. 2012 Sep;40(9):2543-51. doi: 10.1097/CCM.0b013e318258fee7.
PMID: 22903091BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Kluge, MD
University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2019
First Posted
July 9, 2019
Study Start
January 1, 2020
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share