Using HA380 hemoadsorption to treat septic shock in ICU patients
Safety and Efficacy of HA380 HEMoadsorption in Combination With OXiris Membrane for Continuous HemoDiaFiltration in Patients With Septic Shock - HEMOX-HDF Trial
This study is testing if a new treatment using HA380 hemoadsorption can help ICU patients with septic shock and kidney problems feel better and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Trial ID | NCT04997421 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of HA380 hemoadsorption combined with continuous veno-venous hemodiafiltration (CVVHDF) in patients suffering from septic shock and acute kidney injury. The study aims to reduce the harmful effects of a cytokine storm and high endotoxin levels that contribute to organ dysfunction and mortality in critically ill patients. Eligible participants include adults admitted to the ICU with septic shock requiring norepinephrine and likely to need continuous renal replacement therapy within 48 hours. The trial will assess the impact of this combined treatment approach on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with septic shock and acute kidney injury requiring intensive care.
Not a fit: Patients who are already on maintenance dialysis or have a very poor prognosis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in patients with septic shock and acute kidney injury.
How similar studies have performed: Other studies have shown promise with similar hemoadsorption techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Maintenance dialysis dependency or RRT during current hospital stay prior to ICU admission * GFR less than 20ml/kg/1.73m2 prior to hospital admission (within 365 days) * Neurosurgical patients * Pregnant women * Patient's lack of commitment to start RRT * Chronic or acute clinical condition with a prognosis below 6 months * History of heparin allergy or heparin induced thrombocytopenia
Where this trial is running
Turku
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Mikko J Järvisalo, MD, PhD — Turku University Hospital
- Study coordinator: Mikko J Järvisalo, MD, PhD
- Email: mikko.jarvisalo@tyks.fi
- Phone: +35823130000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.