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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02413541
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nattachai Srisawat ,M.D., Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Procedure: Polymyxin-B Hemoperfusion Procedure: Standard treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413541


Locations
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Thailand
Sasipha Tachaboon
Bangkok, Pathumwan, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nattachai Srisawat ,M.D., Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02413541    
Other Study ID Numbers: IRB.NO.575/56
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Polymyxins
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents