Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection

NCT02871024 | Terminated

• 1 other identifier: 201411023RIPB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited. Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related severe sepsis will attenuate sepsis associated microcirculation failure and result in early reversal of shock and less extent of end-organ damage.

Conditions

Sepsis

Keywords

Polymyxin B; Pneumonia; Sepsis; Urinary tract infection

Outcome Measures

Primary Outcomes (1)

• Reversal of sepsis-associated circulatory failure

  Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.

  Day 7

Secondary Outcomes (8)

• Lactate clearance of survived subjects

  Day 3

• Change of endotoxin levels (Endotoxin Activity Assay)

  Day 3

• Change of Sequential Organ Failure Assessment (SOFA) score

  Day 7

• Vasopressor-free days

  7 days

• 28-day all-cause mortality

  28 days

Study Arms (1)

Intervention arm

EXPERIMENTAL

Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart

Device: Toraymyxin

Interventions

Toraymyxin DEVICE

Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock
• Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:
• Pneumonia is defined by a new infiltrate on chest radiograph and the presence of one or several of the following signs or symptoms: cough, sputum production, dyspnea, core body temperature ≥ 38.0°C, auscultatory findings of abnormal breath sounds and rales and leukocyte count \> 10000 or \< 4000/L.
• UTI is defined by at least one clinical symptom (core body temperature ≥38.0°C, urinary urgency, polyuria, dysuria, suprapubic pain, flank pain, costovertebral angle tenderness, nausea and vomiting) and one urinary criterion (pyuria \>20 leukocytes/μL).
• Hyperlactatemia (\>2 mmol/L)
• Endotoxin activity assay (EAA) ≥ 0.5 units.

You may not qualify if:

• Shock persisted \>12 hours before screening
• Mechanical ventilation \>21 days
• Uncontrolled hemorrhage
• Thrombocytopenia (platelet count \< 30,000 cells/mm3)
• Leukopenia (leukocyte count \< 1500 cells/mm3)
• Suspected allergy to polymyxin
• Females with pregnancy
• Terminal cancer or organ failure with life expectancy less than 30 days

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Sepsis; Pneumonia; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sheng-Yuan Ruan, MD

  Natioanl Taiwan University Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sheng-Yuan Ruan MD

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

TW (1)