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

NCT03974386 | Completed

• 1 other identifier: 201808098DIPC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis, Severe; Septic Shock

Keywords

critical care; septic shock; hemofiltration; endotoxin; cytokine storm; prognosis

Outcome Measures

Primary Outcomes (1)

• Difference of serum interleukin-6 level

  Comparison to enrollment or between 2 groups

  24 hours

Secondary Outcomes (32)

• Difference of serum interleukin-6 level

  48 hours

• Difference of serum interleukin-6 level

  72 hours

• Difference of serum interleukin-1β level

  24 hours

• Difference of serum interleukin-1β level

  48 hours

• Difference of serum interleukin-1β level

  72 hours

Study Arms (2)

Blood Purification

EXPERIMENTAL

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

Conventional Treatment

NO INTERVENTION

Patients will receive standard care, including resuscitation and treatment according to current guidelines for septic shock.

Interventions

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.

Blood Purification

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: July 1, 2019
• Primary Completion: July 17, 2020
• Study Completion: August 20, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

TW (1)