Sepsis Clinical Trial
Official title:
The Incidence of Renal Impairment Associated With Polymyxin E Treatment and the Impact of Measuring Colistin Levels
Colistin is a relatively old antibiotic drug which its use has been abandoned through the
1970s because it was considered nephrotoxic.
Recently ( the last decade) it has been reappraised because multidrug resistant Gram
negative bacteria have emerged causing life threatening infections with no other good enough
treatment. Moreover, more controlled studies from the recent years show less toxic effect of
the drug.
The investigators' study is a prospective study comparing renal function in a group of
hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin
(antibiotics) with a control group which its patients receive other non nephrotoxic
antibiotics.
The investigators' study hypothesis is that patients receiving Colistin would have renal
function decline in higher rates than those seen usually in hospitalized patients in the
Internal medicine wards with sepsis.
Another goal of the study is to find correlation between Colistin levels in the plasma
(after Colistin reaches steady state) and nephrotoxicity seen during or after use of this
drug.
Colistin is a relatively old antibiotic drug which its use has been abandoned through the
1970s because it was considered nephrotoxic.
Recently ( the last decade) it has been reappraised because multidrug resistant Gram
negative bacteria have emerged causing life threatening infections with no other good enough
treatment. Moreover, more controlled studies from the recent years show less toxic effect of
the drug.
The investigators' study is a prospective study comparing renal function in a group of
hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin
(antibiotics) with a control group which its patients receive other non nephrotoxic
antibiotics.
The investigators' study hypothesis is that patients receiving Colistin would have renal
function decline in higher rates than those seen usually in hospitalized patients in the
Internal medicine wards with sepsis.
Another goal of the study is to find correlation between Colistin levels in the plasma
(after Colistin reaches steady state) and nephrotoxicity seen during or after use of this
drug.The measurement of the Colistin levels are planned to be done by immunological methods,
by developing specific antibodies to Colistin in a laboratory in France.
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