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临床试验/NCT06411080
NCT06411080已完成不适用

UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury: A Pilot Randomized Controlled Trial

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Protocol adherence

研究概览

简要总结

Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (AKI). While it is generally accepted that the timely correction of kidney hypoperfusion will minimize the extent of injury as well as potentially facilitate recovery, there are potential harms involved in indiscriminate administration of intravenous fluids. Although anticipating fluid tolerance is part of the clinical evaluation of a patient for whom intravenous fluid therapy is considered, it has been suggested that using Point-Of-Care ultrasound (POCUS) may enable the early identification of patients with a high-risk of congestive complications and guide clinical decisions with greater precision[1]. However, it has not been shown that providing this information in the context of AKI result in a change in management or a prevention of complications.

This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance to usual care in non-critically ill patients with AKI. In the intervention group, a POCUS evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team. This assessment will be repeated 48-72 hours later. The primary aim of the study will be to establish the feasibility of this intervention. Secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration, diuretic use, evolution of kidney function, and intensification of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

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

  • Adults ≥ 18 year-old
  • Admitted to the hospital
  • Acute kidney injury defined by the KDIGO criteria[48]
  • Fluid expansion is considered by attending nephrologist or already ongoing

排除标准

  • Admitted to the intensive care unit
  • Known stage 5 chronic kidney disease according to the KDIGO classification receiving renal replacement therapy or not.
  • Renal replacement therapy for AKI has been initiated or is planned within 24 hours

结局指标

主要结局

Protocol adherence

时间窗: 30 days

: Ultrasound assessments were performed as planned and the reports were generated and transmitted to the attending care team in the prespecified periods.

次要结局

  • Cumulative intravenous fluid(5 days)
  • Diuretic use(5 days)
  • Kinetic estimated glomerular filtration rate (KeGFR)(5 days)
  • Progression to a higher stage of AKI(5 days)
  • Death or escalation of care(10 days)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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