The Incidence of Renal Impairment Associated With Polymyxin E Treatment and the Impact of Measuring Colistin Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum creatinine changes.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients diagnosed with sepsis requiring antibiotic treatment
- •Age 18 years old and above
- •Gender - male or female
排除标准
- •Anticipated antibiotic treatment of less than 7 consecutive days
- •Concurrent treatment with other nephrotoxic antibiotic drug
研究组 & 干预措施
Treatment
Patients with sepsis treated with polymyxin E (colistin)
干预措施: Polymyxin E (Colistin) (Drug)
Control
Patients with sepsis treated with other, non-nephrotoxic antibiotic medication
干预措施: Non-nephrotoxic antibiotics (Drug)
结局指标
主要结局
Serum creatinine changes.
时间窗: Blood examination every 3 days until discharge
次要结局
- Mortality(During hospitalization)
- Correlation between creatinine levels and colistin levels(During hospitalization)