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临床试验/NCT03961503
NCT03961503已完成不适用

Acute Kidney Injury During Daptomycin Versus Vancomycin Treatment in Cardiovascular Critically Ill Patients: a Propensity Score Matched Analysis

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Incidence of Acute Kidney Injury (AKI)

研究概览

简要总结

Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery. AKI compromises seriously short and long-term prognosis of critically ill patients. Several AKI risk factors have been identified including a chronic pathology of the patient such as kidney failure or diabetes, acute kidney injury related to hemodynamic disorders during surgery, including cardiopulmonary bypass, or sepsis, and the use of nephrotoxic agents such as some antibiotics, colloids or iodine contrast agents. Avoiding nephrotoxic agents is therefore strongly recommended in ICU patients, to reduce the incidence of AKI, or to reduce its severity.

The aim of this cohort study was to assess whether the use of daptomycin, was associated to a lower incidence of AKI than vancomycin in cardiovascular ICU patients, with similar efficacy.

This is a retrospective observational study with a propensity score adjustment to reduce the bias of selection for a comparative analysis between two antibacterial treatments used in routine care.

Since treatments were not randomized, the investigators used the propensity score method for primary endpoint analysis. For this, the investigators included the covariates potentially related to treatment and outcome in a multivariate logistic model explaining the choice of treatment. This propensity score was used in the second model as an adjustment covariate included in the multivariate analysis to determine factors independently associated with the primary endpoint (AKI within 7 days).

The main hypothesis is the first line antibiotic treatment with daptomycin leads to less nephrotoxicity than vancomycin in a population known at high risk for AKI and with at least a similar efficacy on clinical success rate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Daptomycin (DAP)

DAP : Cohort of patients who received daptomycin as the first line treatment for at least 48 hours for the defined indication

干预措施: Daptomycin (DAP) treatment (Drug)

Vancomycin (VAN)

VAN : Cohort of patients who received vancomycin as the first line treatment for at least 48 hours for the defined indication

干预措施: Vancomycin (VAN) treatment (Drug)

结局指标

主要结局

Incidence of Acute Kidney Injury (AKI)

时间窗: 7 days after the treatment initiation

AKI stade 1, 2 or 3 according to KDIGO definition with baseline creatinine given by the last creatinine value before the start of treatment

次要结局

  • Duration of RRT(Through study completion limited to ICU stay, an average of 2 weeks)
  • Incidence of clinical treatment failure(15 days after the end of treatment)
  • Incidence of Acute Kidney Injury (AKI)(14 days after the treatment initiation)
  • Maximal decrease of glomerular filtration rate (GFR)(Through study treatment completion, an average of 2 weeks)
  • Incidence of renal replacement therapy (RRT)(Through study treatment completion, an average of 2 weeks)
  • Incidence of premature discontinuation of treatment(Through study treatment completion, an average of 2 weeks)
  • Incidence of severe renal failure(Through study treatment completion, an average of 2 weeks)
  • Mortality(6 months (180 days) after treatment initiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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