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

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ClinicalTrials.gov Identifier: NCT02413541
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Nattachai Srisawat ,M.D., Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE March 31, 2015
First Posted Date  ICMJE April 10, 2015
Last Update Posted Date March 5, 2021
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • Functions of cell surface markers [ Time Frame: 3 days ]
    CD11b expression on PMN and HLA-DR expression on monocyte
  • Chemotaxis [ Time Frame: 3 days ]
    Neutrophil function
  • EAA level [ Time Frame: 3 days ]
    Endotoxin level
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Severe Sepsis
Intervention  ICMJE
  • Procedure: Polymyxin-B Hemoperfusion
    Endotoxin removal
  • Procedure: Standard treatment
Study Arms  ICMJE
  • Experimental: High EAA and use Polymyxin-B Hemoperfusion
    EAA level > 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion
    Intervention: 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
    Intervention: Procedure: Standard treatment
  • Active Comparator: Low EAA
    EAA level < 0.6 and not use Polymyxin-B Hemoperfusion
    Intervention: Procedure: Standard treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02413541
Other Study ID Numbers  ICMJE IRB.575/56
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nattachai Srisawat ,M.D., Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chulalongkorn University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP