Clinical effects of direct hemoperfusion using a polymyxin-B immobilized column in solid organ transplanted patients with signs of severe sepsis and septic shock. A pilot study.
BACKGROUND
Polymyxin B (PMX-B) is a polycationic antibiotic, known to bind the lipid A portion of endotoxin, a cell wall component found exclusively in gram negative bacteria (GNB). An extracorporeal hemoperfusion device (TORAYMYXIN) has been developed: PMX is covalently bound on the surface of an insoluble carrier material so that the endotoxin can be inactivated in the blood without exerting its toxicity on the brain and kidney. The aim of this study was to clarify the efficacy, safety and clinical effects of direct hemoperfusion with an immobilized polymyxin-B fiber column (DHP-PMX) in solid organ transplanted patients with severe sepsis or septic shock.


METHODS
From June 2004 to May 2005, 15 patients (10 men and 5 women), mean age 55 years old (46-65 range), underwent kidney or liver transplantation and developed severe sepsis or septic shock, as defined by the Consensus Conference of American College Physicians/Society of Critical Care Medicine (ACCP/SCCM) criteria. GNB were detected in all the patients receiving conventional treatments including antibiotic therapy, vasopressive or inotropic agents, and ventilation support. The DHP-PMX treatment was performed three times in each patient. Hemodynamic and respiratory parameters, dosage of vasopressor/inotropic drugs were assessed at baseline and after each treatment.


RESULTS
No adverse events occurred. From baseline to 3rd treatment, mean arterial pressure (MAP) was increased (from 63+/-5 to 83+/-4 mmHg), while the dosage of dobutamine (from 7.5+/-3 to 3+/-2 mcg/kg/min) and noradrenaline (from 1.3+/-0.45 to 0.05+/-0.02 mcg/kg/min) were reduced. The PaO2/FiO2 ratio increased (from 234+/-38.47 to 290+/-107.48 mmHg).


CONCLUSIONS
The use of DHP-PMX in association with conventional therapy may be an important aid in patients with sepsis.
Ruberto
F
F
Department of Anesthesiology, Critical Care Medicine and Pain Therapy, Sapienza University of Rome, Rome, Italy. rube2005@libero.it
Pugliese
F
F
D'Alio
A
A
Martelli
S
S
Bruno
K
K
Marcellino
V
V
Summonti
D
D
Celli
P
P
Perrella
S
S
Cappannoli
A
A
Pietropaoli
C
C
Tosi
A
A
Diana
B
B
Novelli
G
G
Rossi
M
M
Ginanni-Corradini
S
S
Ferretti
G
G
Berloco
P B
PB
Pietropaoli
P
P
D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004731:Endotoxins / Q000037:antagonists & inhibitors; D005260:Female; D006464:Hemoperfusion / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011112:Polymyxin B / Q000627:therapeutic use*; D012772:Shock, Septic / Q000209:etiology / Q000628:therapy*; D016060:Sorption Detoxification / Q000379:methods*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004731:Endotoxins; D011112:Polymyxin B