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NCT02413541 Clinical Trial

The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis

Severe Sepsis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02413541
Other study ID # IRB.575/56
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date August 30, 2017

Study information
Verified date March 2021
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date August 30, 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - SIRS Criteria > or = 2 meets definition - Source of infection > or = 1 meet definition - Evidence of organ dysfunction > or = 1 meet definition Exclusion Criteria: - WBC < 5,000 /ul - Platelet < 30,000 / ul - Pregnancy woman - Advance stage cancer patients (terminally ill) who is refuse to be resuscitated - Received blood transfusion > 5 units in 24 hrs - Allergy to Polymyxin-B - High risk and uncontrolled bleeding - Organ transplant patients - On immunosuppressive agents within 2 weeks before study - HIV infection

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Polymyxin-B Hemoperfusion
Endotoxin removal
• Standard treatment

Locations
Country Name City State
Thailand Sasipha Tachaboon Bangkok Pathumwan

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functions of cell surface markers CD11b expression on PMN and HLA-DR expression on monocyte 3 days
Primary Chemotaxis Neutrophil function 3 days
Primary EAA level Endotoxin level 3 days
Secondary Survival rate 28 days
Secondary Sequential Organ Failure Assessment (SOFA Score) 28 days
Secondary Acute Kidney Injury and Renal Replacement Therapy incidences 28 days
Secondary ICU length of stay 28 days
Secondary Mechanical ventilation free day 28 days
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