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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

Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date July 4, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
Difference of serum interleukin-6 level [ Time Frame: 24 hours ]
Comparison to enrollment or between 2 groups
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03974386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • Difference of serum interleukin-6 level [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-6 level [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-1β level [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-1β level [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-1β level [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-10 level [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-10 level [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum interleukin-10 level [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum procalcitonin level [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum procalcitonin level [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum procalcitonin level [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of mean arterial pressure [ Time Frame: 24 hours ]
    Comparison to enrollment
  • Difference of mean arterial pressure [ Time Frame: 48 hours ]
    Comparison to enrollment
  • Difference of mean arterial pressure [ Time Frame: 72 hours ]
    Comparison to enrollment
  • Difference of cardiac output [ Time Frame: 24 hours ]
    Comparison to enrollment
  • Difference of cardiac output [ Time Frame: 48 hours ]
    Comparison to enrollment
  • Difference of cardiac output [ Time Frame: 72 hours ]
    Comparison to enrollment
  • Difference of norepinephrine infusion rate [ Time Frame: 24 hours ]
    Comparison to enrollment
  • Difference of norepinephrine infusion rate [ Time Frame: 48 hours ]
    Comparison to enrollment
  • Difference of norepinephrine infusion rate [ Time Frame: 72 hours ]
    Comparison to enrollment
  • Difference of the sequential organ failure assessment score [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of the sequential organ failure assessment score [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of the sequential organ failure assessment score [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum endocan level [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum endocan level [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum endocan level [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum diamine oxidase level [ Time Frame: 24 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum diamine oxidase level [ Time Frame: 48 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of serum diamine oxidase level [ Time Frame: 72 hours ]
    Comparison to enrollment or between 2 groups
  • Difference of daily IV fluids [ Time Frame: 24 hours ]
    Comparison between 2 groups
  • Difference of daily IV fluids [ Time Frame: 48 hours ]
    Comparison between 2 groups
  • Difference of daily IV fluids [ Time Frame: 72 hours ]
    Comparison between 2 groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock
Official Title  ICMJE Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis, Severe
  • Septic Shock
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: oXiris blood purification set
  • No Intervention: Conventional Treatment
    Patients will receive standard care, including resuscitation and treatment according to current guidelines for septic shock.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yu-Chang Yeh 886-9-10513711 tonyyeh@ntuh.gov.tw
Contact: Ching-Tang Chiu 886-9-72653395 chiu99@ntuh.gov.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974386
Other Study ID Numbers  ICMJE 201808098DIPC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP