Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis

Phase 4

Completed

• Conditions: Gram-Negative Bacterial Infections; Sepsis; Septic Shock
• Interventions: Device: Polymyxin B immobilized fiber column; Other: Conventional medical therapy in the ICU

• Registration Number: NCT00629382
• Lead Sponsor: St. Bortolo Hospital

Brief Summary

This clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis arising from abdominal cavity infection, accompanied by the failure of one or more organs. 120 patients (60 treatment/60 control) will be considered in this study. Those patients fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to one of two study groups. One group will be treated with PMX (PMX group) and the other will receive a "standard therapy" for sepsis (control group). All patients will receive full intensive care management, including fluid resuscitation, vasopressors, antimicrobial chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient will be followed up for 28 days after study entry.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Status Verified: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2008-12-01
• Last Update Posted: 2008-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with severe sepsis due to intra-abdominal cavity infection after emergency surgery with at least 2 SIRS criteria and 1 organ dysfunction (as defined by SCCM)

Exclusion Criteria

• Less than 18 years of age
• Females with a positive pregnancy test
• Treated with another investigational drug or device within the 30 days immediately preceding enrolment in this study
• Undergone organ transplantation during the past one year
• Documented history of sensitivity to Polymyxin-B, anticoagulant (heparin)
• Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as "Do Not Resuscitate"
• Diagnosed with HIV
• Previous history of end stage chronic organ failure(s)
• Uncontrolled hemorrhage within the last 24 h
• Diagnosed with granulocytopenia (leukocyte count of less than 500 cells/mm3) and/or thrombocytopenia (platelet count of less than 30,000 cells/mm3)
• More than 4 failed organs at entry
• An APACHE II score of more than 30 at entry to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Polymyxin B immobilized fiber column	-
1	Conventional medical therapy in the ICU	-
2	Conventional medical therapy in the ICU	-

Primary Outcome Measures

Name	Time	Method
Blood pressure and use of vasopressors	48-72 hrs

Secondary Outcome Measures

Name	Time	Method
Change in SOFA score	48-72 hrs
ICU survival	28 days
PaO2/ FiO2 ratio	48-72 hrs

Trial Locations

Locations (1)

St Bortolo Hospital; 🇮🇹 Vicenza, Italy