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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02413541
Enrollment
90
Registered
2015-04-10
Start date
2015-01-31
Completion date
2017-08-30
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis

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.

Interventions

Endotoxin removal

PROCEDUREStandard treatment

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functions of cell surface markers3 daysCD11b expression on PMN and HLA-DR expression on monocyte
Chemotaxis3 daysNeutrophil function
EAA level3 daysEndotoxin level

Secondary

MeasureTime frame
ICU length of stay28 days
Survival rate28 days
Mechanical ventilation free day28 days
Sequential Organ Failure Assessment (SOFA Score)28 days
Acute Kidney Injury and Renal Replacement Therapy incidences28 days

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026