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

March 3, 2021 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumwan
      • Bangkok, Pathumwan, Thailand, 10330
        • Sasipha tachaboon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Endotoxin removal
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB.575/56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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