Adjuvant Therapy With CytoSorb in Refractory Septic Shock

NCT ID: NCT04013269

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

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.

Detailed Description

The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide.

The clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%.

This high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CytoSorb-Therapy

Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy in combination with haemadsorption using CytoSorb-Adsorber

Group Type: ACTIVE_COMPARATOR

CytoSorb-Therapy

Intervention Type: DEVICE

Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy

Standard of care

Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CytoSorb-Therapy

Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Refractory septic shock
• Need for Norepinephrine ≥ 0.25 µg/kg/min
• IL6 ≥ 1000 ng/l
• Indication for CRRT

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytoSorbents, Inc

INDUSTRY

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Kluge, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dominik Jarczak, MD

Role: CONTACT

d.jarczak@uke.de

+49 40 741035315

Axel Nierhaus, MD

Role: CONTACT

nierhaus@uke.de

+49 40 741035315

Facility Contacts

Dominik Jarczak, MD

Role: primary

d.jarczak@uke.de

+49 40 741035315

Axel Nierhaus, MD

Role: backup

nierhaus@uke.de

+49 40 741035315

References

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.

Reference Type: BACKGROUND

PMID: 28537517 (View on PubMed)

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):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.

Reference Type: BACKGROUND

PMID: 28589286 (View on PubMed)

Garau 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.

Reference Type: BACKGROUND

PMID: 30481999 (View on PubMed)

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. doi: 10.1186/s13054-017-1662-9.

Reference Type: BACKGROUND

PMID: 28343448 (View on PubMed)

Bayer 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.

Reference Type: BACKGROUND

PMID: 22903091 (View on PubMed)

Other Identifiers

DRKS00015483

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACYSS

Identifier Type: -

Identifier Source: org_study_id