Linking the Effects of 9/11 to Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 1
- 主要终点
- glomerular filtration rate (eGFR)
研究概览
简要总结
This study focuses on the prevalence and identification of kidney disease among participants of the WTC Health Program and the study team are planning to assess kidney disease in a multi-factorial manner. The first aim of this study is to correlate kidney dysfunction with 9/11 exposure, and the study team predicts that exposure to 9/11 is an independent risk factor in kidney disease among the WTC Health Program participants. Secondly, the study team proposes that a well-established WTC-related condition, obstructive sleep apnea (OSA), is independently associated with kidney disease. In addition, the study team believe there is a temporal causative relationship between evidence of kidney disease and the severity of OSA. Finally, the last aim is to further identify and explore potential mechanisms and phenotypes of kidney disease in participants of the WTC Health Programs.
Regardless of whether the analyses support or reject these hypotheses, the findings will be of equally great public health importance. Successful completion of the proposed research would address a critical knowledge gap regarding the risk of kidney damage among this group of patients, and would inform future mechanistic studies with the potential to impact prevention.
详细描述
Exposure to environmental toxins results in significant long-term health effects in workers. More than 91,000 rescue and recovery workers and volunteers at the World Trade Center (WTC) sustained exposure to thousands of tons of coarse and fine particulate matter. Thousands of responders are currently treated for WTC-related health conditions or may be at risk for worsening health. Toxic effects of particulate matter are known to affect the pulmonary, renal and cardiovascular systems. The specific effects of the exposure to 9/11 are partly known, and require further investigation, as outlined in the Zadroga Act (Public Law111-347).
This study builds on the preliminary data to address a critical knowledge gap about the risk of kidney damage among WTC responders, the progression of kidney decline since exposure, and the association of kidney disease with a defined WTC-related diagnosis, obstructive sleep apnea (OSA). Successful completion of the proposed research would address a critical knowledge gap regarding the risk of kidney damage and the relationship to important chronic diseases (OSA and immune-mediated disease) among WTC participants, and would inform future mechanistic studies with the potential to impact disease prevention.
Specific Aim 1: To quantify the risk of kidney damage and the relationship to 9/11 exposure among WTC Health Program participants. Currently, the cohort of 406 first responders represents the sole dedicated evaluation of kidney disease in WTC Health Program participants. The study team will test the hypothesis that exposure to 9/11 is independently associated with kidney disease and enrich the enrollment of the current study population with a diversified population including categories of workers who have not been enrolled, as well as a control group of urban workers (NYC) not exposed to the dust from the WTC.
Aim 1a. The study team hypothesize that albuminuria and decreased estimated glomerular filtration rate (eGFR) will occur more frequently in WTC responders than in the general population and will correlate with the degree of exposure as defined by the previously defined WTC exposure score (adjusting for demographics, family history of chronic kidney disease (CKD), and diagnosed, treated or laboratory confirmed diabetes and hypertension). The study team will also assess established urine biomarkers of proximal tubular injury, including β2-M, Kidney Injury Molecule-1 (KIM-1), and Interleukin 18 (IL-18), as well as markers of distal tubular function, Loop of Henle function, and tubulointerstitial inflammation.
Aim 1b. The study team hypothesize that initial exposure to 9/11 contributed to reduction in renal function over time. The study team will quantify change in renal function over time by analyzing eGFR at WTC Health Program Visit 1 (V1) and subsequent visits, adjusting for known co-morbid conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposed Group: - Adult patients (35 to 75 years)
- •Enrolled or was seen at any of the WTC Clinical Centers of Excellence
- •Unexposed Group: - Adult patients (35 to 75 years)
- •Lived or worked in NYC at least 10 years since 9/11/01 but were not exposed to the the dust at Ground Zero (not living in proximity of Ground Zero, nor involved in the rescue and recovery at Ground Zero
- •Registry Part: - Adult patient (18 to 75 years)
- •Enrolled or was seen at any of the WTC Clinical Centers of Excellence or WTC Environmental Health Centers
- •With a diagnosis of any Kidney Injury or disease after 9/11/01
排除标准
- •Patients below 18 years of age
- •Individuals with an occupation involving chronic exposure to inhaled particulate matter (e.g. iron/steel workers and sand hog workers)
- •For the registry part, patients with kidney disease prior to 9/11/01
结局指标
主要结局
glomerular filtration rate (eGFR)
时间窗: day 1
eGFR will be calculated using the Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equations. The proposed studies will evaluate differences in the combined creatinine-cystatin C eGFR, which provides the most accurate estimate of GFR, and the creatinine-based CKD-EPI eGFR, which is more practical for use in clinical practice and in monitoring programs. Values \> 200 will be set to 200mL/min/1.73m2
albuminuria
时间窗: day 1
albumin level in urine
次要结局
- apnea-hypopnea index (AHI)(day 1)
- Berlin questionnaire(day 1)
研究者
Maryann Mclaughlin
Associate Professor
Icahn School of Medicine at Mount Sinai
