Safety and Efficacy of HA380 HEMoadsorption in Combination With OXiris Membrane for Continuous HemoDiaFiltration in Patients With Septic Shock - HEMOX-HDF Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Intensive care unit (ICU) mortality in patients with septic shock and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) remains high and approximates 50-60%. Sepsis is the leading etiology for AKI and CRRT requirement in ICU patients. In septic shock, the dysregulated host response to infectious pathogens leads to a cytokine storm with uncontrolled production and release of humoral pro-inflammatory mediators. These pro-inflammatory mediators and cytokines exert cellular toxicity and promote the development of organ dysfunction and increased mortality. In addition to treating AKI, CRRT techniques can be employed for adsorption of inflammatory mediators extracorporally using specially developed adsorption membranes, hemoperfusion sorbent cartridges or columns. Several methods and devices, such as Oxiris®-AN69 membrane, CytoSorb® cytokine hemoadsorption and polymyxin B (Toraymyxin) endotoxin adsorption and plasmapheresis have been evaluated in small study series but to date the data on outcome benefits remains controversial. HA380 (Jafron Biomedical Co , Ltd, Zhuhai, China) is a CE-labeled hemoadsorption cartridge developed to treat patients with septic shock. It contains hemo-compatible, porous polymeric beads that adsorp cytokines and mid-molecular weight toxins on their surface. The cytokines absorved using this cartridge are IL-1, IL-6, IL-8, IL-10 in addition to TNF-α8. Therefore, this study aims to examine the potential effects of cytokine adsorption using HA380 in addition to hemodiafiltration with the Oxiris®-AN69 membrane on ICU- and 90-day mortality in patients with septic shock and AKI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Age \>18 years, admitted to the ICU

• Septic shock according to the Sepsis-3 criteria and a norepinephrine requirement ≥0.2µg/kg/min despite adequate fluid resuscitation

• Acute kidney injury at or after ICU admission and the treating physician considers that initiation of CRRT is likely within 48 hours.

• Informed consent from the patient or family members is received

Locations
Other Locations
Finland
Turku University Hospital
RECRUITING
Turku
Contact Information
Primary
Mikko J Järvisalo, MD, PhD
mikko.jarvisalo@tyks.fi
+35823130000
Backup
Panu Uusalo, MD, PhD
panu.uusalo@tyks.fi
+35823130000
Time Frame
Start Date: 2021-06-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Active_comparator: CVVHDF with Oxiris®-AN69 membrane
Control arm
Active_comparator: CVVHDF with Oxiris®-AN69 membrane + Hemoadsorption using HA380
Intervention arm
Related Therapeutic Areas
Sponsors
Collaborators: University of Turku
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov