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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02871024
Date of registration: 04/08/2016
Prospective Registration: No
Primary sponsor: National Taiwan University Hospital
Public title: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
Scientific title: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial
Date of first enrolment: August 2016
Target sample size: 1
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02871024
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Sheng-Yuan Ruan, MD
Address: 
Telephone:
Email:
Affiliation:  Natioanl Taiwan University Hospital, Taiwan
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Sepsis
Intervention(s)
Device: Toraymyxin
Primary Outcome(s)
Reversal of sepsis-associated circulatory failure [Time Frame: Day 7]
Secondary Outcome(s)
Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day [Time Frame: 3 days]
28-day all-cause mortality [Time Frame: 28 days]
Catheter-related complications [Time Frame: 3 days]
Lactate clearance of survived subjects [Time Frame: Day 3]
Thrombocytopenia (<25,000/µL) [Time Frame: 3 days]
Vasopressor-free days [Time Frame: 7 days]
Change of Sequential Organ Failure Assessment (SOFA) score [Time Frame: Day 7]
Change of endotoxin levels (Endotoxin Activity Assay) [Time Frame: Day 3]
Secondary ID(s)
201411023RIPB
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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