CLinical Efficacy of Hemoperfusion With a Cytokine Adsorber in Norepinephrine-Resistant SEptic Shock (CLEANSE)
Septic Shock, Cytokine Storm
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Sepsis, Septic shock, Hemoperfusion, Blood purification, HA-330
Eligibility Criteria
Inclusion Criteria:
- Septic shock patients, according to The Third International Consensus Definitions for Sepsis and Septic Shock and
- Is receiving intravenous norepinephrine 0.2 mcg/kg/min or more, or equivalent dose of other vasoactive agents
Exclusion Criteria:
One who has
- acute coronary syndrome
- life-threatening arrhythmias
- acute ischemic stroke
- life-threatening, uncontrolled bleeding
- underlying conditions judged to have with limited life expectancy (less than 6 months) by primary physicians
One who is
- judged by treating physicians as in moribund state and expected not to survive to 24 hours regardless of treatment given
- known to be pregnant at enrollment
- not in the competent state to give informed consent and not having relatives to do so
- not willing to pursue intensive medical therapy considered standard of care for patients with septic shock
Sites / Locations
- Faculty of Medicine Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of care
Standard of care, with hemoperfusion with HA-330
Patients randomized to this arm are treated with standard of care for patients with septic shock, including Fluid resuscitation and vasoactive agents Hemodynamic monitoring in intensive care units Antibiotics and infection source control, when applicable Supportive therapies and devices, including mechanical ventilation and renal replacement therapy Immunoregulatory medications, including systemic corticosteroids All treatment provided are according to treating physicians
Patients randomized to this arm are treated with standard of care for patients with septic shock as described for 'Standard of care' arm, along with hemoperfusion with HA-330 Disposable Hemoperfusion Cartridge, as detailed under 'Interventions'