Renal Impairment Associated With Colistin Levels

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023087
• Other study ID #: COLISTIN.RF.10
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: July 24, 2011
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: July 2010
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Insufficiency
• Sepsis

Intervention

Drug:
• Polymyxin E (Colistin)
Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.
• Non-nephrotoxic antibiotics
To be decided by the infectious disease consultant

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine changes.		Blood examination every 3 days until discharge	Yes
Secondary	Mortality		During hospitalization	Yes
Secondary	Correlation between creatinine levels and colistin levels		During hospitalization	No