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临床试验/NCT06372444
NCT06372444招募中不适用

Mechanisms of Acute Kidney Injury in Severe Infections

Uppsala University Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年5月1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
15
试验地点
1
主要终点
Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET)

研究概览

简要总结

Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations.

详细描述

To study renal perfusion and neutrophil-mediated inflammation 10 critically ill patients with sepsis and acute kidney injury (AKI) and 5 healthy volunteers as controls will be recruited and examined at one time with marked water followed by neutrophil elastase tracer. At the same time, a CT scan is performed for anatomy. Plasma levels of inflammatory mediators will be measured. Clinical data will be collected. The endpoints are changes in renal perfusion and increased presence of neutrophil elastase in the renal parenchyma.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients with sepsis and AKI
  • > 30 years
  • At least AKI stage 1 according to KDIGO where the last plasma creatinine is measured within 24 hours of the examination
  • Healthy volunteers
  • > 30 years
  • No previously known kidney disease
  • Normal plasma creatinine value

排除标准

  • Chronic renal failure (CKD stage >3a) or dialysis
  • Instability in vital functions that makes PET-CT examination unsuitable
  • Claustrophobia or other reasons that make the patient unable to lie still during the examination.
  • Pregnancy and breastfeeding

结局指标

主要结局

Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET)

时间窗: PET performed within days of AKI

vs controls

Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET)

时间窗: PET performed within 10 days of AKI

vs controls

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miklos Lipcsey

Professor

Uppsala University Hospital

研究点 (1)

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