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
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
- 否
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
ZhiYong Peng
Professor; Chief physician
Zhongnan Hospital
