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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2021 |
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Main ID: |
NCT02413541 |
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Date of registration:
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31/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Date of first enrolment:
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January 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02413541 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Sepsis
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Intervention(s)
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Procedure: Standard treatment
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Procedure: Polymyxin-B Hemoperfusion
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Primary Outcome(s)
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Functions of cell surface markers
[Time Frame: 3 days]
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EAA level
[Time Frame: 3 days]
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Chemotaxis
[Time Frame: 3 days]
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Secondary Outcome(s)
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Sequential Organ Failure Assessment (SOFA Score)
[Time Frame: 28 days]
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Survival rate
[Time Frame: 28 days]
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Mechanical ventilation free day
[Time Frame: 28 days]
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ICU length of stay
[Time Frame: 28 days]
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Acute Kidney Injury and Renal Replacement Therapy incidences
[Time Frame: 28 days]
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Secondary ID(s)
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IRB.575/56
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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