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临床试验/NCT05659589
NCT05659589招募中不适用

Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
105
试验地点
2
主要终点
Change of pulse wave velocity (PWV) measurement from baseline

研究概览

简要总结

Acute kidney injury (AKI) is a frequent disease in conventional hospital departments and in intensive care units. It's associated with a high risk to develop chronic kidney disease (CKD), even after a single small AKI episode. It's also associated with an important morbi-mortality, particularly cardiovascular (CV). Some studies have already showed a link between AKI and CV risk but pathologic mechanisms implicated are still unknown. In AKI and CKD, numerous substances, called uremic toxins (UT) are accumulating in blood. In CKD, those toxins, and particularly Indoxyl sulfate (IS), are known to have cardiac and vascular deleterious consequences. However, in AKI, whether acute accumulation of UT may trigger CV complications is unknown.

The purpose of this study is that during AKI, a high UT concentration, in particular IS, would be associated with early vascular and cardiac dysfunctions that can be characterized by the persistence of an accelerated pulse wave velocity (PWV). The main objective is to evaluate the correlation between UT concentrations (especially IS) and arterial stiffness (PWV measurement) at three months of an AKI episode in conventional hospital departments and in the intensive care unit of nephrology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • Age over 18 years old.
  • Patients hospitalized in conventional hospital departments and in intensive care units of nephrology.
  • Patients with moderate to severe AKI (KDIGO 2 or 3) without dialysis.
  • AKI from functional or organic aetiology

排除标准

  • Patients with severe CKD (GFR<45ml/min/1.73 m2) or with kidney transplants.
  • Patients with AKI from septic or obstructive aetiology.
  • Patients with AKI from toxic aetiology whose toxic would be also responsable of cardia toxicity.
  • Patients with sepsis or blood inflammation.
  • Patients with severe chronic cardia dysfunction.
  • Patients with arrhythmia or complete heart block.
  • Patients with peripheral artery occlusive disease.
  • Pregnancy.
  • Patients on palliative care.

结局指标

主要结局

Change of pulse wave velocity (PWV) measurement from baseline

时间窗: at 3 months

次要结局

  • Correlation between Para-cresyl Sulfate (PCS) concentration and PWV(3 months)
  • Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV(3 months)
  • Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function(3 months)
  • Correlation between IS concentration and arterial pressure measurement(3 months)
  • Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement(3 months)
  • Correlation between IS concentration and cardiac diastolic function(3 months)
  • Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement(3 months)
  • Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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