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

Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Sepsis

Intervention: Polymyxin-B Hemoperfusion (Procedure); Standard treatment (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Chulalongkorn University

Overall contact:
Nattachai Srisawat, M.D., Phone: 66818361891, Email: drnattachai@yahoo.com

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome:

Functions of cell surface markers

Chemotaxis

EAA level

Secondary outcome:

Survival rate

Sequential Organ Failure Assessment (SOFA Score)

Acute Kidney Injury and Renal Replacement Therapy incidences

ICU length of stay

Mechanical ventilation free day

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Nattachai Srisawat, M.D., Phone: 66818361891, Email: drnattachai@yahoo.com

Sasipha Tachaboon, Bangkok, Pathumwan 10330, Thailand; Recruiting
Additional Information

Starting date: January 2015
Last updated: April 7, 2015

Page last updated: August 23, 2015

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