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

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ClinicalTrials.gov Identifier: NCT03974386
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Sepsis, Severe Septic Shock Device: oXiris blood purification set Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Blood Purification
Patients will receive resuscitation and treatment according to current guidelines for septic shock. In addition to standard care, the patients will receive continuous venovenous hemofiltration and adsorption with oXiris blood purification set.
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.

No Intervention: Conventional Treatment
Patients will receive standard care, including resuscitation and treatment according to current guidelines for septic shock.



Primary Outcome Measures :
  1. Difference of serum interleukin-6 level [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974386


Contacts
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Contact: Yu-Chang Yeh 886-9-10513711 tonyyeh@ntuh.gov.tw
Contact: Ching-Tang Chiu 886-9-72653395 chiu99@ntuh.gov.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yu-Chang Yeh, M.D, Ph.D.    886-2-23123456    tonyyeh@ntuh.gov.tw   
Principal Investigator: Yu-Chang Yeh, M.D., Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03974386     History of Changes
Other Study ID Numbers: 201808098DIPC
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
critical care
septic shock
hemofiltration
endotoxin
cytokine storm
prognosis
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Shock
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation