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临床试验/NCT05710978
NCT05710978撤回不适用

Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

State University of New York at Buffalo2 个研究点 分布在 1 个国家开始时间: 2022年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
[TIMP-2 x IGFBP-7] concentration

研究概览

简要总结

Prolonged, high intensity work in a hot environment results in significant strain on the body, known as heat strain. Heat strain in hot occupational settings such as agriculture, fire suppression, and military work can lead to ~20% of workers exceeding the glomerular filtration rate indicated thresholds for acute kidney injury (AKI). However, it is unclear whether these individuals truly experienced AKI or if these were normal, healthy physiologic responses. To better determine if AKI occurs in the staggering number of workers previously reported, AKI biomarkers are needed in addition to kidney function markers (e.g., glomerular filtration rate) to characterize this response. The product of urinary tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) is a promising Food and Drug Administration approved biomarker indicating risk of AKI and is currently used in hospitalized individuals. The usefulness of this biomarker in determining AKI in healthy individuals during heat strain is now beginning to be understood. Consecutive days of heat strain can result in repeated AKI, which is hypothesized to lead to chronic kidney disease. There is an epidemic of chronic kidney disease of non-traditional causes occurring in workers who undergo repeated days heat strain, including approximately 15% of outdoor workers in Central America. Of the few studies that investigated consecutive days of work in the heat, we demonstrated that participants exceed the glomerular filtration rate indicated threshold for AKI during consecutive days of heat strain. This project will determine whether [TIMP-2 x IGFBP7] increases during occupational relevant heat exposures in a healthy, active population. Additionally, this project will compare the impact of repeated exposures to a hot environment on risk of AKI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals (18-39 years old)
  • Regularly completes aerobic exercise at least 60 min per week

排除标准

  • History of cardiovascular, metabolic, respiratory, neural, or renal disease
  • Hypertensive or tachycardic during the screening visit (systolic blood pressure > 139 mmHg, diastolic blood pressure > 89 mmHg, heart rate > 100 bpm)
  • Current tobacco or nicotine use or previous regular use within the past 2 years
  • Current or previous musculoskeletal injury limiting physical activity
  • Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
  • A positive pregnancy test at any point during the study or currently breastfeeding
  • Study physician discretion based on any other medical condition or medication

结局指标

主要结局

[TIMP-2 x IGFBP-7] concentration

时间窗: Hour 5

The product of \[Tissue inhibitor of metalloproteinase 2 (TIMP-2) and Insulin-like growth factor binding protein 7 (IGFBP7)\] is a biomarker that has the potential for prediction of acute kidney injury.

次要结局

  • Serum creatinine concentration(Hour 5)
  • Urine creatinine concentration(Hour 5)
  • NGAL concentration(Hour 5)

研究者

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

Riana Pryor

Principal Investigator

State University of New York at Buffalo

研究点 (2)

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