Nadroparin Pharmacokinetics in Different Stages of COVID-19-a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in nadroparin concentration in blood measurement
研究概览
简要总结
Objective:
The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. The aim of this study was to develop a pharmacokinetic model of LMWH (nadroparin calcium) according to different stages of COVID-19 severity.
Design:
The investigators performed a prospective observational study.
Patients:
Blood samples were obtained from 43 COVID-19 patients that received nadroparin and were treated with conventional oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation.
Setting:
The investigators recorded clinical, biochemical, and hemodynamic variables during 72 hours of treatment. The analyzed data comprised 782 serum nadroparin concentrations and 219 anti-factor Xa levels. The investigators conducted population nonlinear mixed-effects modeling (NONMEM) and performed Monte Carlo simulations of the probability of target attainment (PTA) for reaching 0.2-0.5 IU/ml anti-Xa levels in study groups.
Interventions: None.
Measurements and Main Results:
The investigators successfully developed a one-compartment model to describe the population pharmacokinetics of nadroparin in different stages of COVID-19.
Conclusions:
Different nadroparin dosing is required for patients undergoing mechanical ventilation and ECMO to achieve the same targets as those for non-critically ill patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •Patients treated in the Department of Anesthesiology and Intensive Care and the Department of Infectious Diseases of a tertiary academic hospital with confirmed SARS-CoV-2 infection with a real-time reverse transcription polymerase chain reaction (RT-PCR) or an antigen test.
排除标准
- •Coagulation disorders at the start of the therapy.
研究组 & 干预措施
conventional oxygen therapy
Patients treated with conventional oxygen in Infectious Diseases Ward.
干预措施: Nadroparin (Drug)
mechanical ventilation
Patients who are mechanically ventilated and treated in ICU.
干预措施: Nadroparin (Drug)
mechanical ventilation and ECMO
Patients who are mechanically ventilated and on ECMO treated in ICU.
干预措施: Nadroparin (Drug)
结局指标
主要结局
Change in nadroparin concentration in blood measurement
时间窗: 6 hours
Sequential measurement every 6 hours
Change in anti-Xa serum level
时间窗: 12 hours
Sequential measurement every 12 hours
次要结局
- Volume of distribution of nadroparin(24 hours)
- Clearance of nadroparin(24 hours)
- Absorption rate of nadroparin(24 hours)
研究者
Paweł Piwowarczyk
Principal Investigator
Medical University of Lublin