Reliable Methods to Assess Kidney Function for Drug Dosage Adjustments in Critically Ill Patients - Comparison of Timed Clearance of Creatinine and Creatinine Based Estimated GFR
试验速览
- 阶段
- 不适用
- 入组人数
- 172
- 主要终点
- composite outcome (combination of nephrotoxicity or treatment failure)
研究概览
简要总结
The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be decided using 4hr CrCl.
详细描述
- Screening periods (From 'informed consents' to 'randomization')
-
Check of inclusion/exclusion criteria ② Measurement of 4hr CrCl & eGFR in ml/min
-
calculation of maintenance dose ③ Baseline characteristics & laboratory findings ④ Randomization
- Colistin dosage Loading dose : 5 x body weight (not exceeding 300mg) Maintenance dose (after 12 hours from loading dose)
: 2.5 x ([1.5 x GFR] + 30) (divided doses every 12hours), GFR in ml/min
During the study period, daily morning serm creatinine levels are measured. Whenever serum creatinine concentration changes by more than 10% compared with baseline, 4hr CrCl will be mearued. At the every time of 4hr CrCl measurements, colistin dose wil be modified according to new GFR values (4hr CrCl in study group, eGFR in control group) 3. Blood sampling for Colistin trough level measurement Peripheral blood will be sampled twice between 72 hrs and 144 hours after loading dose, just before colistin infusion. The samples were collected in heparined tubes and centrifuged at 4 °C within 1 hr of collection. The resulting plasma was stored at - 70°C . And two values will be averaged out. 4. End of randomization (7 days after colistin initiation) ① Nephrotoxicity ② Treatment outcome microbiological outcome: eradication / no eradication clinical outcome: complete response / partial response / treatment failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients aged over 18
- •Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.
排除标准
- •Patients who received colistin empirically.
- •Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
- •Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
- •Patients who underwent hematopoietic stem cell transplantation
- •Patients who disagree with this study.
结局指标
主要结局
composite outcome (combination of nephrotoxicity or treatment failure)
时间窗: 7 days after colistin initiation
Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'
次要结局
- In-ICU mortality (infection-attributed mortality)(till discharge (Max. 3 months))
- colistin trough level, renal clearance of colistin(7 days after colistin initiation)
- ICU stay duration(till discharge (Max. 3 months))
- Need for renal replacement therapy(7 days after colistin initiation)
- Total duration of colistin treatment(till discharge (Max. 3 months))
研究者
Jung Eun Lee
Associate professor
Samsung Medical Center