UnknownNot Applicable

Blood Purification in Patients With Septic Shock

Taiwan120 participantsStarted 2021-09-16

Plain-language summary

In recent years, many studies have pointed out that bacterial toxin storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Critically ill patients with severe septic shock * Intraabdominal infection, proved or highly suspected gram-negative bacteria infection * Change of sequential organ failure assessment (SOFA) score is above or equal to 2 * Require norepinephrine infusion to maintain mean arterial pressure above 65 mm Hg * Lactate level above 4 mmol/L * SOFA score \>= 9 or norepinephrine dose \> 0.1 mcg/kg/min Exclusion Criteria: * Aged \< 20 * SOFA score \>=16 * Lactate level \>=16 * High dose norepinephrine infusion (\> 0.3 mcg/kg/min) more than 24 h after SOFA score was \>=9 * High dose norepinephrine infusion (\> 0.3 mcg/kg/min) more than 24 h after Lactate level was \>=4 * White blood cell counts \< 1000 cells/μL * Platelet counts \< 30 K/μL * Allergy to heparin * Receive continuous renal replacement therapy \>8 hour before enrollment * Receive other endotoxin removal filter * Receive cardiopulmonary resuscitation within 4 weeks before enrollment * Admitted to ICU for severe septic shock within 4 weeks before enrollment * APACHE II score \> 35 at enrollment

What they're measuring

Duration of vasopressors and inotropes infusion

Timeframe: up to 10 days

Trial details

NCT IDNCT04957316

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Yu-Chang Yeh, MD, PhD

+886-9-68661829 tonyyeh@ntuh.gov.tw