Renal Impairment Associated With Colistin Levels
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Serum creatinine changes. [Blood examination every 3 days until discharge]
Secondary Outcome Measures
- Mortality [During hospitalization]
- Correlation between creatinine levels and colistin levels [During hospitalization]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 |
Sponsors and Collaborators
- Shaare Zedek Medical Center
Investigators
- Study Chair: Moshe Hersch, MD; MSc., Shaare Zedek Medical Center, Jerusalem
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COLISTIN.RF.10