Renal Impairment Associated With Colistin Levels

Completed

• Conditions: Sepsis
• Interventions: Drug: Non-nephrotoxic antibiotics; Drug: Polymyxin E (Colistin)

• Registration Number: NCT01023087
• Lead Sponsor: Shaare Zedek Medical Center

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Status Verified: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-07-24
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Non-nephrotoxic antibiotics	Patients with sepsis treated with other, non-nephrotoxic antibiotic medication
Treatment	Polymyxin E (Colistin)	Patients with sepsis treated with polymyxin E (colistin)

Primary Outcome Measures

Name	Time	Method
Serum creatinine changes.	Blood examination every 3 days until discharge

Secondary Outcome Measures

Name	Time	Method
Correlation between creatinine levels and colistin levels	During hospitalization
Mortality	During hospitalization

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel