Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy
2015年4月21日 更新者:Avera McKennan Hospital & University Health Center
Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit
This study is an observational analysis that monitors the effect of different dialysis methods on vancomycin levels when patients are critically ill.
No changes are made to therapy based on levels, but levels are checked more frequently than normal.
The primary dialysis methods being studied are SLED (slow-low efficiency daily) dialysis and intermittent hemodialysis.
Vancomycin is the only medication being evaluated in this study.
This study will provide detailed information on how to dose vancomycin in patients that are on dialysis in the intensive care unit.
研究概览
详细说明
The proposed study will evaluate the pharmacokinetics of vancomycin in patients that are on being treated with various types of renal replacement therapy.
The renal replacement therapies studied in this trial will be slow-low efficiency daily (SLED) dialysis and intermittent hemodialysis.
This data will be collected and plotted for vancomycin for each dialysis mechanism utilized and plotted on drug concentration versus time graphs to determine drug clearance in each type of renal replacement therapy.
Subjects will have blood samples drawn and sent to the laboratory according to the dialysis method studied (9 for SLED dialysis and 10 samples for intermittent hemodialysis).
Serial levels will be drawn prior to the drug being administered and after the drug is infused to assess the clearance and distribution of vancomycin.
Study drug levels will be drawn from blood that is already available in the laboratory when timing of such samples is appropriate, in order to limit the amount of blood that is drawn from each study subject.
A total of 30 milliliters of blood will be collected from each subject for any one study arm they fit into.
Blood will be collected no more than two times per week and only more than once in a particular patient if their dialysis regimen changes.
A single particular subject will only be able to supply blood samples once for each dialysis regimen being studied.
This study would allow for the data collection of vancomycin levels at several time points during renal replacement therapy to assess the pharmacokinetic parameters associated with vancomycin dosing in each specialized patient-dialysis combination.
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
South Dakota
-
Sioux Falls、South Dakota、美国、57117
- Avera McKennan Hospital and University Health Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients must be admitted to the intensive care unit at Avera McKennan Hospital in Sioux Falls, SD.
描述
Inclusion Criteria:
- > 18 years of age
- One of the following types of dialysis modalities implemented:
Slow-low efficiency daily dialysis Intermittent hemodialysis
- Use of study medication (vancomycin)
Exclusion Criteria:
- Inability to give informed consent
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
1
Slow-low efficiency daily dialysis group
|
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
其他名称:
10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.
其他名称:
|
2
Intermittent Hemodialysis group
|
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
其他名称:
10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin.
大体时间:4 months
|
4 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Bradley Beck, Pharm.D.、Avera McKennan Hospital and University Health Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kielstein JT, Czock D, Schopke T, Hafer C, Bode-Boger SM, Kuse E, Keller F, Fliser D. Pharmacokinetics and total elimination of meropenem and vancomycin in intensive care unit patients undergoing extended daily dialysis. Crit Care Med. 2006 Jan;34(1):51-6. doi: 10.1097/01.ccm.0000190243.88133.3f.
- Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159-66. doi: 10.1086/444500. Epub 2005 Sep 12.
- Pai AB, Pai MP. Vancomycin dosing in high flux hemodialysis: a limited-sampling algorithm. Am J Health Syst Pharm. 2004 Sep 1;61(17):1812-6. doi: 10.1093/ajhp/61.17.1812.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年12月1日
初级完成 (实际的)
2009年4月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2009年2月19日
首先提交符合 QC 标准的
2009年2月19日
首次发布 (估计)
2009年2月20日
研究记录更新
最后更新发布 (估计)
2015年4月22日
上次提交的符合 QC 标准的更新
2015年4月21日
最后验证
2015年4月1日
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.