Clinical trial NCT00629382: Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis
Official title: Dispositivo Adsorbente Con Polymyxina B Immobilizzata Nello Shock Settico - Studio Clinico Randomizzato e Prospettico, Multicentrico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gram-Negative Bacterial Infections
Sepsis
Septic Shock
Keywords: abdominal sepsis
abdominal surgery
septic shock
polymyxin B
hemoperfusion
Endotoxins
Lead sponsor: St. Bortolo Hospital
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Blood pressure and use of vasopressors
timeFrame: 48-72 hrs
Secondary outcomes:
measure: PaO2/ FiO2 ratio
timeFrame: 48-72 hrs
measure: Change in SOFA score
timeFrame: 48-72 hrs
measure: ICU survival
timeFrame: 28 days
Other outcomes:
Locations:
city: Vicenza
country: Italy
facility: St Bortolo Hospital
Study officials:
References:
citation: 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. doi: 10.1186/cc5780.
citation: 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. doi: 10.1001/jama.2009.856.