跳至主要内容
临床试验/NCT06472999
NCT06472999招募中不适用

Implementation of Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury (AKI) - an Observational Study

Universität Münster3 个研究点 分布在 3 个国家目标入组 257 人开始时间: 2024年7月24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
257
试验地点
3
主要终点
Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria)

研究概览

简要总结

This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.

详细描述

Acute kidney injury (AKI) is a global problem affecting more than 10% of all hospitalized patients and up to 50% of critically ill patients, with survival related not only to the severity,1 but also to the duration of renal dysfunction.2 Recent evidence suggests that two-thirds of patients with AKI resolve their renal dysfunction within 3-7 days whereas those in whom renal dysfunctions persist have dramatically reduced survival over the following year.2 Persistence of AKI is of grave importance in that it increases an individual's risk of developing chronic kidney disease (CKD) which is a major cause of morbidity and mortality. This link between AKI and CKD has been established over the last decade3 and specific recommendations for the management of patients with AKI have been proposed in order to potentially influence this transition.4 To date, there are no specific pharmacological options for preventing or treating AKI, which is why new approaches and intensive efforts are urgently needed to reduce the occurrence of AKI. The Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines recommend implementing a bundle of different supportive measures, which, in theory, should be initiated in all patients with AKI in order to prevent disease progression. However, clinical practice and recent studies have shown that the implementation of the KDIGO bundle is still not standard clinical practice despite the fact that evidence suggest clear effectiveness in the reduction of AKI rates.5-9 Poor implementation of nephroprotective measures presents a major missed opportunity to reduce AKI-related morbidity and mortality and to improve long-term outcomes. To investigate the extent to which nephroprotective measures are implemented in patients with AKI can reduce the occurrence of persistent surgical AKI, a multi-center prospective cohort study will be performed.

研究设计

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

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

  • Critically ill patients with moderate or severe AKI (KDIGO stage 2 / 3)
  • Requirement of vasopressors or mechanical ventilation
  • Age ≥ 18 years
  • Informed consent

排除标准

  • Chronic kidney disease (CKD) with a glomerular filtration rate < 20ml/min
  • Chronic dialysis dependency
  • History of renal transplantation
  • Permanent ligation of the renal arteries
  • AKI immediately following nephrectomy
  • Patients requiring permanent administration of nephrotoxic drugs (e.g. immunosuppressive therapy afer liver transplantation)
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.

结局指标

主要结局

Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria)

时间窗: 60 hours after onset of moderate/severe AKI

次要结局

  • Severity of Acute Kidney Injury(within 72 hours after diagnosis)
  • Duration of AKI (Acute Kidney Injury)(from onset of AKI until follow-up day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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