NCT02413541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 31, 2015

Last Update Submit

March 3, 2021

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (3)

  • Functions of cell surface markers

    CD11b expression on PMN and HLA-DR expression on monocyte

    3 days

  • Chemotaxis

    Neutrophil function

    3 days

  • EAA level

    Endotoxin level

    3 days

Secondary Outcomes (5)

  • Survival rate

    28 days

  • Sequential Organ Failure Assessment (SOFA Score)

    28 days

  • Acute Kidney Injury and Renal Replacement Therapy incidences

    28 days

  • ICU length of stay

    28 days

  • Mechanical ventilation free day

    28 days

Study Arms (3)

High EAA and use Polymyxin-B Hemoperfusion

EXPERIMENTAL

EAA level \> 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion

Procedure: Polymyxin-B Hemoperfusion

High EAA and not use Polymyxin-B Hemoperfusion

EXPERIMENTAL

EAA level \> 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion

Procedure: Standard treatment

Low EAA

ACTIVE COMPARATOR

EAA level \< 0.6 and not use Polymyxin-B Hemoperfusion

Procedure: Standard treatment

Interventions

Polymyxin-B HemoperfusionPROCEDURE

Endotoxin removal

High EAA and use Polymyxin-B Hemoperfusion
Standard treatmentPROCEDURE
High EAA and not use Polymyxin-B HemoperfusionLow EAA

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SIRS Criteria \> or = 2 meets definition
  • Source of infection \> or = 1 meet definition
  • Evidence of organ dysfunction \> or = 1 meet definition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sasipha Tachaboon

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (2)

  • Singhan W, Vadcharavivad S, Areepium N, Wittayalertpanya S, Chaijamorn W, Srisawat N. The effect of direct hemoperfusion with polymyxin B immobilized cartridge on meropenem in critically ill patients requiring renal support. J Crit Care. 2019 Jun;51:71-76. doi: 10.1016/j.jcrc.2019.02.007. Epub 2019 Feb 5.

    PMID: 30769293DERIVED

  • Srisawat N, Tungsanga S, Lumlertgul N, Komaenthammasophon C, Peerapornratana S, Thamrongsat N, Tiranathanagul K, Praditpornsilpa K, Eiam-Ong S, Tungsanga K, Kellum JA. The effect of polymyxin B hemoperfusion on modulation of human leukocyte antigen DR in severe sepsis patients. Crit Care. 2018 Oct 26;22(1):279. doi: 10.1186/s13054-018-2077-y.

    PMID: 30367647DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Nephrology, Department of Medicine, Faculty of Medicine

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 10, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

August 30, 2017

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

TH(1)