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Completed

NCT Number: NCT02413541

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

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sasipha Tachaboon

Bangkok, Pathumwan, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymyxin-B Hemoperfusion

Procedure

Endotoxin removal

Standard treatment

Procedure

Primary outcomes

  1. Functions of cell surface markers

    Time frame: 3 days

    CD11b expression on PMN and HLA-DR expression on monocyte

  2. Chemotaxis

    Time frame: 3 days

    Neutrophil function

  3. EAA level

    Time frame: 3 days

    Endotoxin level

Secondary outcomes

  1. Survival rate

    Time frame: 28 days

  2. Sequential Organ Failure Assessment (SOFA Score)

    Time frame: 28 days

  3. Acute Kidney Injury and Renal Replacement Therapy incidences

    Time frame: 28 days

  4. ICU length of stay

    Time frame: 28 days

  5. Mechanical ventilation free day

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Apr 10, 2015
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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