Levosimendans Pharmacokinetics in Intensive Care Patients. An Observational Study. (LEFKIP)
Levosimendans Pharmacokinetics in Intensive Care Patients
研究概览
详细说明
Aims: To gain a better understanding of the pharmacokinetics of Levosimendan in critically ill patients and in particular in those patients with and without renal failure and in those receiving CRRT. This project may give a better basis to determine whether dose monitoring and adjustment of Levosimendan is necessary to avoid toxicity or under treatment. In order to study Levosimendan pharmacokinetics, the Karolinska laboratory has in parallel developed a method for analysis of the substance and its metabolites.
Research questions:
- To what extent are Levosimendan and its active metabolites dialysable in patients receiving continuous renal replacement therapy.
- How do the concentrations of Levosimendan and its active metabolites differ in critically ill patients with and without acute renal failure?
Method:
The is a prospective observational study conducted on adult intensive care units at Karolinska University Hospital.
Study Population: Critical care patients who due to clinical need are prescribed Levosimendan by treating physician will be included into one of three groups based on degree of AKI (KDIGO classification) and need for CRRT. This is a non-interventional study.
Number of patients to be included: we intend to include 4-12 patients per group.
Procedure: The decision to prescribe Levosimendan will be made by treating physicians as will decisions regarding dose, dose adjustment and length of treatment.
Screening for inclusion will occur when a decision to prescribe Levosimendan has been made.
Samples of blood, urine and ultrafiltration fluid from the CRRT circuit are to be analysed to determine concentration of Levosimendan and its metabolites. Plasma concentrations will be obtained, before and after the dialysis filter.
Concentration monitoring will occur over a period of up to 6 days, with test taken at 0, 6 and 20 hours after infusion start and after cessation of Levosimendan every two hours for the first 10 hours and there after twice a day for the next 5 days. A maximum of 30 samples (15 in non CRRT patients) of 1-3ml are taken.
Patient groups:
Group 1: Levosimendan + no AKI or KDIGO AKI stage 1. Group 2: Levosimendan + KDIGO AKI stage 2-3, not CRRT Group 3: Levosimendan + KDIGO AKI stage 1-3 with CRRT.
Analysis:
Analysis of the plasma concentration of Levosimendan and its metabolites (OR-1896, OR-1855) is performed at the clinical pharmacology department, Karolinska University Hospital. Reference substances have been provided by Orion Pharma.
Definitions:
Acute Kidney Failure (AKI) is defined according to the KDIGO definition: Creatinine entry from the baseline (percentage increase) and volume of urine production or CRRT treatment.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Claire Rimes-Stigare, MD, PhD
- 电话号码:004651770000
- 邮箱:claire.rimes-stigare@regionstockholm.se
研究联系人备份
- 姓名:Susanne Rysz, MD, PhD
- 电话号码:004651770000
- 邮箱:susanne.rysz@regionstockholm.se
学习地点
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Stockholm、瑞典
- 招聘中
- Karolinska University Hospital
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接触:
- Claire Rimes-Stigare, MD, PhD
- 电话号码:004651770000
- 邮箱:claire.rimes-stigare@regionstockholm.se
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接触:
- Susanne, MD
- 电话号码:004651770000
- 邮箱:sussanne.rysz@regionstockholm.se
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Intensive Care Unit patients in whom the treating physician has decided due to clinical indication to administer levosimendan. Dose and length of treatment decided by treating physician.
With Group 1: No renal failure or Acute Kidney Injury(AKI)* stage 1. Group 2: AKI stage 2-3, not receiving renal replacement therapy. Group 3: Receiving continuous renal replacement therapy (CRRT)
*AKI classification system Kidney Disease Improving Global outcomes (KDIGO)
描述
Inclusion Criteria:
° Adult Intensive care patients in whom treating physicians have judged to be in need of Levosimendan treatment.
Exclusion Criteria:
- Patient <18 years of age
- Pregnancy
- Patients receiving Intermittent hemodialysis
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Concentration of levosimendan and OR 1896 1855 in plasma
大体时间:1-5 days
|
Plasma concentrations of levosimendan and its active metabolites afte Levosimendan infusion.
|
1-5 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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