Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock

Septic Shock Clinical Trial

Official title:

Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974386
• Other study ID #: 201808098DIPC
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: March 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 20, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• oXiris blood purification set
Continuous venovenous hemofiltration and adsorption (CVVHA) with oXiris filter for up to 72 hours if required. The filter will be replaced every 24 hours. The setting of CVVHA is as follows: blood flow rate 200 mL/min, replacement fluid rate 2000 mL/hr, pre-dilution 50% and post-dilution 50%. If continuous renal replacement therapy is indicated after 72 hours, conventional hemofiltration filters will be used.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of serum interleukin-6 level	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of serum interleukin-6 level	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of serum interleukin-6 level	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of serum interleukin-1ß level	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of serum interleukin-1ß level	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of serum interleukin-1ß level	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of serum interleukin-10 level	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of serum interleukin-10 level	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of serum interleukin-10 level	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of serum procalcitonin level	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of serum procalcitonin level	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of serum procalcitonin level	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of mean arterial pressure	Comparison to enrollment	24 hours
Secondary	Difference of mean arterial pressure	Comparison to enrollment	48 hours
Secondary	Difference of mean arterial pressure	Comparison to enrollment	72 hours
Secondary	Difference of cardiac output	Comparison to enrollment	24 hours
Secondary	Difference of cardiac output	Comparison to enrollment	48 hours
Secondary	Difference of cardiac output	Comparison to enrollment	72 hours
Secondary	Difference of norepinephrine infusion rate	Comparison to enrollment	24 hours
Secondary	Difference of norepinephrine infusion rate	Comparison to enrollment	48 hours
Secondary	Difference of norepinephrine infusion rate	Comparison to enrollment	72 hours
Secondary	Difference of the sequential organ failure assessment score	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of the sequential organ failure assessment score	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of the sequential organ failure assessment score	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of serum endocan level	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of serum endocan level	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of serum endocan level	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of serum diamine oxidase level	Comparison to enrollment or between 2 groups	24 hours
Secondary	Difference of serum diamine oxidase level	Comparison to enrollment or between 2 groups	48 hours
Secondary	Difference of serum diamine oxidase level	Comparison to enrollment or between 2 groups	72 hours
Secondary	Difference of daily IV fluids	Comparison between 2 groups	24 hours
Secondary	Difference of daily IV fluids	Comparison between 2 groups	48 hours
Secondary	Difference of daily IV fluids	Comparison between 2 groups	72 hours