Renal Impairment Associated With Colistin Levels
Information source: Shaare Zedek Medical Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis
Intervention: Polymyxin E (Colistin) (Drug); Non-nephrotoxic antibiotics (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Shaare Zedek Medical Center Overall contact:
Moshe Hersch, MD, Phone: 972-2-6555164, Email: hersch@szmc.org.il
Summary
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.
Clinical Details
Official title: The Incidence of Renal Impairment Associated With Polymyxin E Treatment and the Impact of Measuring Colistin Levels
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Serum creatinine changes.
Secondary outcome: MortalityCorrelation between creatinine levels and colistin levels
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hospitalized patients diagnosed with sepsis requiring antibiotic treatment
- Age 18 years old and above
- Gender - male or female
Exclusion Criteria:
- Anticipated antibiotic treatment of less than 7 consecutive days
- Concurrent treatment with other nephrotoxic antibiotic drug
Locations and Contacts
Moshe Hersch, MD, Phone: 972-2-6555164, Email: hersch@szmc.org.il
Shaare Zedek Medical Center, Jerusalem 91031, Israel
Additional Information
Starting date: December 2009
Last updated: December 1, 2009
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