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

NCT ID: NCT02871024

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-03-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

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

Group Type: EXPERIMENTAL

Toraymyxin

Intervention Type: DEVICE

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

Interventions

Toraymyxin

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock

2. Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:

2-1. 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.

2-2. 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).

3. Hyperlactatemia (>2 mmol/L)

4. Endotoxin activity assay (EAA) ≥ 0.5 units.

Exclusion Criteria

1. Shock persisted >12 hours before screening

2. Mechanical ventilation >21 days

3. Uncontrolled hemorrhage

4. Thrombocytopenia (platelet count < 30,000 cells/mm3)

5. Leukopenia (leukocyte count < 1500 cells/mm3)

6. Suspected allergy to polymyxin

7. Females with pregnancy

8. Terminal cancer or organ failure with life expectancy less than 30 days

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ms. Ying Ting Chao

Sheng-Yuan Ruan MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheng-Yuan Ruan, MD

Role: PRINCIPAL_INVESTIGATOR

Natioanl Taiwan University Hospital, Taiwan

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201411023RIPB

Identifier Type: -

Identifier Source: org_study_id