Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis - Full Text View

Sponsor:	St. Bortolo Hospital
Information provided by:	St. Bortolo Hospital
ClinicalTrials.gov Identifier:	NCT00629382

Purpose

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.

Condition	Intervention	Phase
Gram-Negative Bacterial Infections Sepsis Septic Shock	Device: Polymyxin B immobilized fiber column Other: Conventional medical therapy in the ICU	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Dispositivo Adsorbente Con Polymyxina B Immobilizzata Nello Shock Settico - Studio Clinico Randomizzato e Prospettico, Multicentrico

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Dietary Fiber Sepsis

Drug Information available for: Polymyxin B Polymyxin B Sulfate

U.S. FDA Resources

Further study details as provided by St. Bortolo Hospital:

Primary Outcome Measures:

Blood pressure and use of vasopressors [ Time Frame: 48-72 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PaO2/ FiO2 ratio [ Time Frame: 48-72 hrs ] [ Designated as safety issue: No ]
Change in SOFA score [ Time Frame: 48-72 hrs ] [ Designated as safety issue: No ]
ICU survival [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	December 2004
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Polymyxin B immobilized fiber column Hemoperfusion with PMX will be performed in ICU. The 1st PMX treatment (day 0) will be carried out for 2 hours and ideally within 24 hours but not later than 48 hours after diagnosis of severe sepsis. The second PMX treatment has to be performed 24 to 48 hours after the end of the first PMX treatment, ideally after 24 hours. Hemoperfusion therapy will be performed in addition to conventional medical therapy in the ICU. Other: Conventional medical therapy in the ICU Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.
2	Other: Conventional medical therapy in the ICU Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.

Arms

Assigned Interventions

1: Experimental

Device: Polymyxin B immobilized fiber column

Hemoperfusion with PMX will be performed in ICU. The 1st PMX treatment (day 0) will be carried out for 2 hours and ideally within 24 hours but not later than 48 hours after diagnosis of severe sepsis. The second PMX treatment has to be performed 24 to 48 hours after the end of the first PMX treatment, ideally after 24 hours. Hemoperfusion therapy will be performed in addition to conventional medical therapy in the ICU.

Other: Conventional medical therapy in the ICU

Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.

2

Other: Conventional medical therapy in the ICU

Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629382

Locations

Italy
St Bortolo Hospital
Vicenza, Italy, 36100

Sponsors and Collaborators

St. Bortolo Hospital

More Information

Publications:

Cruz DN, Perazella MA, Bellomo R, de Cal M, Polanco N, Corradi V, Lentini P, Nalesso F, Ueno T, Ranieri VM, Ronco C. Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care. 2007;11(2):R47. Review.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52.

Responsible Party:	International Renal Research Institute Vicenza (IRRIV), ( Claudio Ronco, MD )
Study ID Numbers:	TM05
Study First Received:	February 26, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00629382 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by St. Bortolo Hospital:

abdominal sepsis
abdominal surgery
septic shock

polymyxin B
hemoperfusion
Endotoxins

Additional relevant MeSH terms:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Polymyxin B
Infection
Pharmacologic Actions
Gram-Negative Bacterial Infections
Inflammation

Anti-Bacterial Agents
Sepsis
Pathologic Processes
Polymyxins
Shock
Therapeutic Uses
Shock, Septic

ClinicalTrials.gov processed this record on February 08, 2010