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临床试验/NCT04277143
NCT04277143Unknown不适用

The Influence Factors of Pharmacokinetics/Pharmacodynamics of Daptomycin in Severe Patients and the the Effect of Different Blood Concentration of Daptomycin on the Outcomes of Renal Function

Zhongnan Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Apparent volume of distribution

研究概览

简要总结

Daptomycin ,is the first approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains,disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of bacterial cell cell wall peptide polysaccharide, changing the properties of cytoplasm membrane, can destroy bacterial cell membrane function in many ways, and quickly kill gram-positive bacteria. Because of its unique chemical structure and sterilization mechanism, bacteria rarely develop resistance to daptomycin. Daptomycin can be reversibility combined with human plasma protein (mainly serum albumin) and metabolized mainly through the kidneys.

There is still a lot of controversy about the application of daptomycin in patients with severe illness. Although studies suggest that daptomycin has less damage to kidney function than vancomycin, the effect of daptomycin on kidney function in severely ill patients is not yet clear, and more clinical studies are needed to explore their relationship. In addition, it is not clear whether the physiological pathology of specific populations such as sepsis/infectious shock, acute kidney injury, (AKI), hypoproteinemia, and renal replacement treatment affects the pharmacokinetics/pharmacodynamics of Daptomycin.

By exploring the application of daptomycin in patients with severe illness, this study explores the effects of special pathological physiological states such as sepsis/infectious shock and hypoproteinemia on daptomycin PK/PD, as well as the effects of different hemoglobin concentrations of daptomycin on the outcome of kidney function.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe bloodstream infections eligible for daptomycin indications
  • Treatment in the ICU
  • Patients aged 18 to 65

排除标准

  • Pregnant and lactating women
  • The patient or his agent refused to participate in the trial
  • Incomplete clinical medical information
  • Patient participates in another clinical trial at the same time
  • Previous history of myopathy or current CPK increase more than 2 times than normal
  • Patients need to use warfarin anticoagulation
  • Patients use tobramycin for anti-infection
  • Patients use drugs such as cyclosporine and fibrates that can cause adverse reactions to muscle disease
  • Patients with Gram-negative bacterial infections caused by abdominal and respiratory infections
  • Patients with heart failure, respiratory failure, Glasgow coma index (GCS) ≤ 8 points, liver function CHILD PUGH score C that are not related to the infection

研究组 & 干预措施

critical ill patient with bloodstream infections

Severe patients with bloodstream infections often have sepsis / septic shock, acute kidney injury (AKI), hypoproteinemia, and renal replacement treatment.

干预措施: Daptomycin (Drug)

结局指标

主要结局

Apparent volume of distribution

时间窗: 1 week

Apparent volume of distribution of daptomycin in the patient's blood

Area under the plasma concentration versus time curve (AUC)

时间窗: 1 week

Area under the plasma concentration versus time curve (AUC) of daptomycin

Blood Urea Nitrogen

时间窗: 1 week

It can reflect kidney function

Urine protein

时间窗: 1 week

Reflect kidney function

Peak plasma concentration

时间窗: 1 week

Peak plasma concentration of daptomycin

Half-life

时间窗: 1 week

Half-life of plasma daptomycin

Protein binding rate

时间窗: 1 week

Reversible binding of daptomycin to plasma proteins (mainly serum albumin)

Urine output

时间窗: 1 week

Urine volume can reflect kidney function

Plasma trough concentration

时间窗: 1 week

Plasma trough concentration of daptomycin

Cystatin C

时间窗: 1 week

Reflect kidney function

β2-microglobulin(β2-MG)

时间窗: 1 week

Reflect kidney function

Major Adverse kidney Event(MAKE)

时间窗: 28days

Major Adverse kidney Event(MAKE)Refers to death, need for renal replacement therapy, and creatinine levels that are twice or more the baseline value;It can reflects the outcome of renal function.

ICU mortality

时间窗: 28days

Reflect patient prognosis

ICU hospital stay length

时间窗: 28 days

Reflect patient prognosis

Total hospital stay length

时间窗: 28 days

Reflect patient prognosis

Clearance of daptomycin

时间窗: 1 week

Daptomycin is metabolized mainly by the kidneys

Serum creatinine

时间窗: 1 week

Serum creatinine can reflect kidney function

In-hospital mortality

时间窗: 28days

Reflect patient prognosis

次要结局

  • Body temperature(1 week)
  • Vascular drug use days(1 week)
  • C-Reactive Protein(1 week)
  • White blood cell count(1 week)
  • Neutrophil ratio(1 week)
  • Procalcitonin(1 week)
  • Interleukin-6(1 week)
  • Bacterial culture results(1 week)

研究者

发起方
Zhongnan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ZhiYong Peng

Professor; Chief physician

Zhongnan Hospital

研究点 (1)

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