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Clinical Trials/NCT02413541
NCT02413541
Completed
Not Applicable

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

Chulalongkorn University1 site in 1 country90 target enrollmentJanuary 2015
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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
August 30, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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