Renal Impairment Associated With Colistin Levels

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Incidence of Renal Impairment Associated With Polymyxin E Treatment and the Impact of Measuring Colistin Levels

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Polymyxin E (Colistin)
* Drug: Non-nephrotoxic antibiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>Patients with sepsis treated with polymyxin E (colistin) | Drug: Polymyxin E (Colistin)<br>* Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.<br>* Other names: Coliracin;|
| Control<br>Patients with sepsis treated with other, non-nephrotoxic antibiotic medication | Drug: Non-nephrotoxic antibiotics<br>* To be decided by the infectious disease consultant<br>* Other names: Non-nephrotoxic antibiotics, as required;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine changes. |  | Blood examination every 3 days until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | During hospitalization | 
| Correlation between creatinine levels and colistin levels |  | During hospitalization |