Renal Impairment Associated With Colistin Levels

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: Polymyxin E (Colistin); Drug: Non-nephrotoxic antibiotics

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients hospitalized in the Department of Internal Medicine with sepsis of any origin.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Study Chair: Moshe Hersch, MD; MSc., Shaare Zedek Medical Center, Jerusalem

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 24, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular; Colistin; Polymyxins
• Other Study ID Numbers: COLISTIN.RF.10