Blood purification for patients with severe septic shock
Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients With Severe Septic Shock
This study is testing if a new blood purification filter can help people with severe septic shock feel better and recover faster by cleaning harmful substances from their blood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04957316 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a triple-effect blood purification filter in patients suffering from severe septic shock. The study aims to determine if this filter can reduce the duration and severity of septic shock by removing harmful endotoxins, cytokines, and urinary toxins from the bloodstream. Patients will be randomly assigned to either a control group receiving standard treatments or a blood purification group receiving the new intervention. The trial will also explore additional clinical outcomes and the extent of organ damage reduction.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients with severe septic shock due to intraabdominal infections and specific organ failure criteria.
Not a fit: Patients with extremely high SOFA scores or those requiring high doses of norepinephrine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and outcomes for patients with severe septic shock.
How similar studies have performed: Other studies have shown promise with similar blood purification approaches, but this specific method is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yu-Chang Yeh, MD, PhD
- Email: tonyyeh@ntuh.gov.tw
- Phone: +886-9-68661829
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.