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

Not Applicable

Completed

• Conditions: Severe Sepsis
• Interventions: Procedure: Polymyxin-B Hemoperfusion; Procedure: Standard treatment

• Registration Number: NCT02413541
• Lead Sponsor: Chulalongkorn University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-10
• Primary Completion: 2015-12
• Study Completion: 2017-08-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High EAA and use Polymyxin-B Hemoperfusion	Polymyxin-B Hemoperfusion	EAA level \> 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion
Low EAA	Standard treatment	EAA level \< 0.6 and not use Polymyxin-B Hemoperfusion
High EAA and not use Polymyxin-B Hemoperfusion	Standard treatment	EAA level \> 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion

Primary Outcome Measures

Name	Time	Method
Chemotaxis	3 days	Neutrophil function
Functions of cell surface markers	3 days	CD11b expression on PMN and HLA-DR expression on monocyte
EAA level	3 days	Endotoxin level

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA Score)	28 days
Survival rate	28 days
Acute Kidney Injury and Renal Replacement Therapy incidences	28 days
ICU length of stay	28 days
Mechanical ventilation free day	28 days

Trial Locations

Locations (1)

Sasipha Tachaboon; 🇹🇭 Bangkok, Pathumwan, Thailand