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

Primary Purpose

Severe Sepsis

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Polymyxin-B Hemoperfusion

Standard treatment

About this trial

This is an interventional treatment trial for Severe Sepsis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sasipha Tachaboon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

High EAA and use Polymyxin-B Hemoperfusion

High EAA and not use Polymyxin-B Hemoperfusion

Low EAA

Arm Description

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

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

EAA level < 0.6 and not use Polymyxin-B Hemoperfusion

Outcomes

Primary Outcome Measures

Functions of cell surface markers

CD11b expression on PMN and HLA-DR expression on monocyte

Chemotaxis

Neutrophil function

EAA level

Endotoxin level

Secondary Outcome Measures

Survival rate

Sequential Organ Failure Assessment (SOFA Score)

Acute Kidney Injury and Renal Replacement Therapy incidences

ICU length of stay

Mechanical ventilation free day

Full Information

NCT ID

NCT02413541

First Posted

March 31, 2015

Last Updated

March 3, 2021

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT02413541

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Sepsis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High EAA and use Polymyxin-B Hemoperfusion

Arm Type

Experimental

Arm Description

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

Arm Title

High EAA and not use Polymyxin-B Hemoperfusion

Arm Type

Experimental

Arm Description

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

Arm Title

Low EAA

Arm Type

Active Comparator

Arm Description

EAA level < 0.6 and not use Polymyxin-B Hemoperfusion

Intervention Type

Procedure

Intervention Name(s)

Polymyxin-B Hemoperfusion

Intervention Description

Endotoxin removal

Intervention Type

Procedure

Intervention Name(s)

Standard treatment

Primary Outcome Measure Information:

Title

Functions of cell surface markers

Description

CD11b expression on PMN and HLA-DR expression on monocyte

Time Frame

3 days

Title

Chemotaxis

Description

Neutrophil function

Time Frame

3 days

Title

EAA level

Description

Endotoxin level

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Survival rate

Time Frame

28 days

Title

Sequential Organ Failure Assessment (SOFA Score)

Time Frame

28 days

Title

Acute Kidney Injury and Renal Replacement Therapy incidences

Time Frame

28 days

Title

ICU length of stay

Time Frame

28 days

Title

Mechanical ventilation free day

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Sasipha Tachaboon

City

Bangkok

State/Province

Pathumwan

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

30769293

Citation

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.

Results Reference

derived

PubMed Identifier

30367647

Citation

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.

Results Reference

derived

Learn more about this trial

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

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