An Observational Explorative Study to Determine Pharmacokinetic Changes of Ceftriaxone in Blood and Ascites in Patients Admitted With Decompensated Liver Cirrhosis With or Without Renal Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clearance (CL) of unbound ceftriaxone
研究概览
简要总结
The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites. The investigators will include a total of 20 patients with liver cirrhosis admitted to the ward of participating hospitals. Patients are eligible when receiving ceftriaxone and concomitantly receive paracentesis. The investigators will collect all available waste blood samples of each participant, starting from study entry up until 48 hours after the last dosing interval of ceftriaxone. The investigators will collect all available waste ascites samples of each participant up until 48 hours after the last dosing interval of ceftriaxone. Duration of the trial: The study duration is variable and depends on the duration of ceftriaxone treatment and duration of hospital admission, which both are determined by the treating physician and is not influenced by study participation. Patients will be eligible for study inclusion when patients received (a single dose of) ceftriaxone treatment and undergo paracentesis during ceftriaxone treatment. The study will end 48 hours after the last dosing interval of ceftriaxone or until hospital discharge, whichever comes first. Study timeline: The investigators expect to enrol 1-2 participants every month. The total enrolment time will thus be approximately 12 months.
详细描述
Objective: The primary objective is to determine the changes in ceftriaxone pharmacokinetics in blood and ascites in patients with decompensated liver cirrhosis to guide ceftriaxone dosing in these patients.
Study design: Observational explorative multicentre study
Study population: Adults (>18 years) with decompensated liver cirrhosis with the presence of ascites admitted to the clinical ward of participating centres who receive ceftriaxone and concomitantly undergo paracentesis during active antibiotic treatment.
Intervention: No intervention, the investigators will only collect the available waste blood and ascites samples.
Main study parameters/endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Clinical, radiological and/or histological diagnosis of liver cirrhosis and portal hypertension
- •Presence of ascites
- •Receiving ceftriaxone in the context of prophylaxis or treatment of infection
- •Indication for diagnostic and/or therapeutic paracentesis
- •Providing oral informed consent
排除标准
- 未提供
研究组 & 干预措施
observational ceftriaxone
Patiënts with liver cirrhosis receiving ceftriaxone treatment.
干预措施: No intervention (observational study) (Other)
结局指标
主要结局
Clearance (CL) of unbound ceftriaxone
时间窗: 12 months
Clearance (CL) of unbound ceftriaxone
Volume of distribution (VD) of unbound ceftriaxone
时间窗: 12 months
Volume of distribution (VD) of unbound ceftriaxone
Penetration rate of unbound ceftriaxone from blood to ascites
时间窗: 12 months
Penetration rate of unbound ceftriaxone from blood to ascites
Elimination rate of unbound ceftriaxone from ascites by paracentesis
时间窗: 12 months
Elimination rate of unbound ceftriaxone from ascites by paracentesis
次要结局
- Target attainment of ceftriaxone in blood, defined as the unbound plasma concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)(12 months)
- Target attainment of ceftriaxone in ascites, defined as the unbound ascites concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)(12 months)
- Explorative analysis on the effect of CKD-stage on individual pharmacokinetic parameters(12 months)
- Explorative analysis on the effect of Child Pugh-score on individual pharmacokinetic parameters(12 months)
- Explorative analysis on the effect of MELD-score on individual pharmacokinetic parameters(12 months)
研究者
Marten A Lantinga, MD PhD
Consultant Hepatology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
