Pharmacokinetics of Meropenem in Patients on Plasma Exchange
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration
研究概览
简要总结
Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥ 18 years
- •hemoglobin ≥ 7 g/dl
排除标准
- •pregnancy or breast-feeding female
- •history of hypersensitivity to carbapenems
- •renal replacement therapy
研究组 & 干预措施
Meropenem: Patients who underwent TPE (Phase 1)
In phase 1, each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first therapeutic plasma exchange (TPE) and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.
干预措施: meropenem (Drug)
Meropenem: after TPE (Phase 2)
was similar to phase 1 except that the meropenem administration and PK studies were conducted >6 hours apart from the next TPE
干预措施: meropenem (Drug)
结局指标
主要结局
The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration
时间窗: 0-8 hours after the drug administration
次要结局
- Maximum plasma concentration [Cmax](0-8 hours after the drug administration)
- Minimum plasma concentration [Cmin](0-8 hours after the drug administration)
- Area under the plasma concentration versus time curve [AUC](0-8 hours after the drug administration)
- half-life [t1/2](0-8 hours after the drug administration)
研究者
Sutep Jaruratanasirikul
Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University
Prince of Songkla University