NCT02413541
Completed
Not Applicable
The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
ConditionsSevere Sepsis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Sepsis
- Sponsor
- Chulalongkorn University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Functions of cell surface markers
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Nattachai Srisawat ,M.D.
Division of Nephrology, Department of Medicine, Faculty of Medicine
Chulalongkorn University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Functions of cell surface markers
Time Frame: 3 days
CD11b expression on PMN and HLA-DR expression on monocyte
EAA level
Time Frame: 3 days
Endotoxin level
Chemotaxis
Time Frame: 3 days
Neutrophil function
Secondary Outcomes
- 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)
Study Sites (1)
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