Clinical trial NCT03974386: Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock
Official title: Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis, Severe
Septic Shock
Keywords: critical care
septic shock
hemofiltration
endotoxin
cytokine storm
prognosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis.

Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.


Eligibility criteria: Inclusion Criteria:

* Patients who meet all criteria (A+B+C):
* A) Identified infection source under adequate treatment
* B) Sepsis (the sequential organ failure assessment score rise 2 points or more)
* C) Severe septic shock (serum lactate \> 2 mmol/L; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is \> 0.2 mcg/kg/min for more than 1 hour or \>0.1 mcg/kg/min for more than 3 hours )

Exclusion Criteria:

* Onset of severe septic shock more than 24 hours
* Received continuous renal replacement therapy within 24 hours before enrollment
* Serum white blood cell count count \< 1000 cells/μL or Platelet count \< 50000 cells/μL
* History of allergy to heparin
* Received cardiopulmonary resuscitation within 4 weeks before enrollment
* ICU admission due to severe septic shock within 2 months
* Patients or Family had chosen palliative care and signed an agreement to deny aggressive treatment
* Pregnancy
* APACHE II Score \> 30 at enrollment
* Non-native speakers

Primary outcomes:
measure: Difference of serum interleukin-6 level
timeFrame: 24 hours
Secondary outcomes:
measure: Difference of serum interleukin-6 level
timeFrame: 48 hours
measure: Difference of serum interleukin-6 level
timeFrame: 72 hours
measure: Difference of serum interleukin-1β level
timeFrame: 24 hours
measure: Difference of serum interleukin-1β level
timeFrame: 48 hours
measure: Difference of serum interleukin-1β level
timeFrame: 72 hours
measure: Difference of serum interleukin-10 level
timeFrame: 24 hours
measure: Difference of serum interleukin-10 level
timeFrame: 48 hours
measure: Difference of serum interleukin-10 level
timeFrame: 72 hours
measure: Difference of serum procalcitonin level
timeFrame: 24 hours
measure: Difference of serum procalcitonin level
timeFrame: 48 hours
measure: Difference of serum procalcitonin level
timeFrame: 72 hours
measure: Difference of mean arterial pressure
timeFrame: 24 hours
measure: Difference of mean arterial pressure
timeFrame: 48 hours
measure: Difference of mean arterial pressure
timeFrame: 72 hours
measure: Difference of cardiac output
timeFrame: 24 hours
measure: Difference of cardiac output
timeFrame: 48 hours
measure: Difference of cardiac output
timeFrame: 72 hours
measure: Difference of norepinephrine infusion rate
timeFrame: 24 hours
measure: Difference of norepinephrine infusion rate
timeFrame: 48 hours
measure: Difference of norepinephrine infusion rate
timeFrame: 72 hours
measure: Difference of the sequential organ failure assessment score
timeFrame: 24 hours
measure: Difference of the sequential organ failure assessment score
timeFrame: 48 hours
measure: Difference of the sequential organ failure assessment score
timeFrame: 72 hours
measure: Difference of serum endocan level
timeFrame: 24 hours
measure: Difference of serum endocan level
timeFrame: 48 hours
measure: Difference of serum endocan level
timeFrame: 72 hours
measure: Difference of serum diamine oxidase level
timeFrame: 24 hours
measure: Difference of serum diamine oxidase level
timeFrame: 48 hours
measure: Difference of serum diamine oxidase level
timeFrame: 72 hours
measure: Difference of daily IV fluids
timeFrame: 24 hours
measure: Difference of daily IV fluids
timeFrame: 48 hours
measure: Difference of daily IV fluids
timeFrame: 72 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: