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

Chulalongkorn University

Status: Completed

Conditions: Severe Sepsis

Treatments: Procedure: Polymyxin-B Hemoperfusion; Procedure: Standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02413541

IRB.575/56

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

High EAA and use Polymyxin-B Hemoperfusion

Experimental group

Description:

EAA level \> 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion

Treatment:

Procedure: Polymyxin-B Hemoperfusion

High EAA and not use Polymyxin-B Hemoperfusion

Experimental group

Description:

EAA level \> 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion

Treatment:

Procedure: Standard treatment

Low EAA

Active Comparator group

Description:

EAA level \< 0.6 and not use Polymyxin-B Hemoperfusion

Treatment:

Procedure: Standard treatment