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NCT Number: NCT03974386

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

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.

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Key information

Conditions

Sepsis, Severe Cytokine Release Syndrome Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oXiris blood purification set

Device

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.

Primary outcomes

  1. Difference of serum interleukin-6 level

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

Secondary outcomes

  1. Difference of serum interleukin-6 level

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  2. Difference of serum interleukin-6 level

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  3. Difference of serum interleukin-1β level

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

  4. Difference of serum interleukin-1β level

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  5. Difference of serum interleukin-1β level

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  6. Difference of serum interleukin-10 level

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

  7. Difference of serum interleukin-10 level

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  8. Difference of serum interleukin-10 level

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  9. Difference of serum procalcitonin level

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

  10. Difference of serum procalcitonin level

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  11. Difference of serum procalcitonin level

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  12. Difference of mean arterial pressure

    Time frame: 24 hours

    Comparison to enrollment

  13. Difference of mean arterial pressure

    Time frame: 48 hours

    Comparison to enrollment

  14. Difference of mean arterial pressure

    Time frame: 72 hours

    Comparison to enrollment

  15. Difference of cardiac output

    Time frame: 24 hours

    Comparison to enrollment

  16. Difference of cardiac output

    Time frame: 48 hours

    Comparison to enrollment

  17. Difference of cardiac output

    Time frame: 72 hours

    Comparison to enrollment

  18. Difference of norepinephrine infusion rate

    Time frame: 24 hours

    Comparison to enrollment

  19. Difference of norepinephrine infusion rate

    Time frame: 48 hours

    Comparison to enrollment

  20. Difference of norepinephrine infusion rate

    Time frame: 72 hours

    Comparison to enrollment

  21. Difference of the sequential organ failure assessment score

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

  22. Difference of the sequential organ failure assessment score

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  23. Difference of the sequential organ failure assessment score

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  24. Difference of serum endocan level

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

  25. Difference of serum endocan level

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  26. Difference of serum endocan level

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  27. Difference of serum diamine oxidase level

    Time frame: 24 hours

    Comparison to enrollment or between 2 groups

  28. Difference of serum diamine oxidase level

    Time frame: 48 hours

    Comparison to enrollment or between 2 groups

  29. Difference of serum diamine oxidase level

    Time frame: 72 hours

    Comparison to enrollment or between 2 groups

  30. Difference of daily IV fluids

    Time frame: 24 hours

    Comparison between 2 groups

  31. Difference of daily IV fluids

    Time frame: 48 hours

    Comparison between 2 groups

  32. Difference of daily IV fluids

    Time frame: 72 hours

    Comparison between 2 groups

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2019
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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