CompletedNCT02413541Updated Mar 5, 2021

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

An interventional study of Polymyxin-B Hemoperfusion and Standard treatment in Severe Sepsis, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-05.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Conditions studied

Severe Sepsis

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Sepsis 1,899

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 90 is below the median of 105 across 896 interventional studies indexed under Sepsis.

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Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts 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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 90 participants (actual)

Study arms

Experimental
High EAA and use Polymyxin-B Hemoperfusion
EAA level \> 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion
Procedure: Polymyxin-B Hemoperfusion
Experimental
High EAA and not use Polymyxin-B Hemoperfusion
EAA level \> 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion
Procedure: Standard treatment
Active comparator
Low EAA
EAA level \< 0.6 and not use Polymyxin-B Hemoperfusion
Procedure: Standard treatment

Interventions

ProcedurePolymyxin-B Hemoperfusion
Endotoxin removal
ProcedureStandard treatment

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Sasipha Tachaboon
Bangkok, Pathumwan 10330, Thailand

References and documents

Publications

Singhan W, Vadcharavivad S, Areepium N, Wittayalertpanya S, Chaijamorn W, Srisawat N. The effect of direct hemoperfusion with polymyxin B immobilized cartridge on meropenem in critically ill patients requiring renal support. J Crit Care. 2019 Jun;51:71-76. doi: 10.1016/j.jcrc.2019.02.007. Epub 2019 Feb 5. PubMed 30769293 ↗
Srisawat N, Tungsanga S, Lumlertgul N, Komaenthammasophon C, Peerapornratana S, Thamrongsat N, Tiranathanagul K, Praditpornsilpa K, Eiam-Ong S, Tungsanga K, Kellum JA. The effect of polymyxin B hemoperfusion on modulation of human leukocyte antigen DR in severe sepsis patients. Crit Care. 2018 Oct 26;22(1):279. doi: 10.1186/s13054-018-2077-y. PubMed 30367647 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02413541
Lead sponsor: Chulalongkorn University
Responsible party: Nattachai Srisawat ,M.D. (Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University) — Principal investigator
First posted: Apr 10, 2015
Start date: Jan 2015
Primary completion: Dec 2015
Completion: Aug 30, 2017
Last update: Mar 5, 2021

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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