跳至主要内容
临床试验/NCT03467854
NCT03467854招募中不适用

Pharmacokinetics (PK) of Piperacillin/Tazobactam in Adults Undergoing Extracorporeal Membrane Oxygenation (ECMO)

Columbia University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Change in clearance rate

研究概览

简要总结

This study is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will have significant changes in concentration measurements, specifically an increased clearance rate and increased volume of distribution, during ECMO as compared to critically ill patients.

详细描述

In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require antimicrobials to treat severe infections. However, little data exist concerning the likely changes in drug concentrations from drug circuit interactions in adult patients receiving ECMO.

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

入选标准

  • Patients 18 years of age or older
  • Initiated on VV ECMO for acute respiratory distress syndrome
  • Receiving piperacillin/tazobactam

排除标准

  • Pregnancy
  • Massive blood transfusion (10 units or more of of PRBC) within a 24-hour period
  • Prisoners

结局指标

主要结局

Change in clearance rate

时间窗: Up to 2 days after the first dose of piperacillin/tazobactam

Change in volume of distribution

时间窗: Up to 2 days after the first dose of piperacillin/tazobactam

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Darryl Abrams

Professor of Medicine

Columbia University

研究点 (1)

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