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The Leicester City and County Chronic Kidney Disease Cohort (LCC-CKD)

2020年1月29日 更新者:University of Leicester

The Leicester City and County Chronic Kidney Disease Study: An Observational Chronic Kidney Disease Cohort to Study Cardiovascular and Renal Outcomes in Multi-ethnicity Primary Care

Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is independently associated with increased cardiovascular (CV) disease risk. This risk increases as CKD advances both in relation to worsening glomerular filtration rate and development of proteinuria. The overall cost of CKD to the NHS (National Health Service) in England has been estimated as £1.45 billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and strokes related to CKD.

The epidemiology of CKD in primary care is poorly studied. This is particularly the case in non-white populations who have an independent higher risk of progression to end stage renal failure (requiring dialysis or transplantation), CV events and death.

Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores. However, all the risk scores had significant methodological limitations, such as a lack of external validation or the perception that they were not 'clinically useful'. The Leicester City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP (general practice) records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years follow-up to the present day. In addition, a present day cohort will be created to both aid research and provide data for practices and clinical commissioning groups for quality improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort.

The principal objectives of the study are:

  1. To study the natural history of CKD in a multi-ethnic primary care setting
  2. To contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD

The risk prediction tool would more accurately stratify risk of CV events for individuals with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing the risk of future myocardial infarctions and strokes. Currently, individuals with CKD, despite higher risk of CV disease, may not be receiving optimum treatment such as statins and anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is likely to see a reduction in CKD associated excess CV events and their associated costs, including longer average duration of inpatient admissions.

研究概览

研究类型

观察性的

注册 (实际的)

25000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Leicestershire
      • Leicester、Leicestershire、英国、Le1 7rh
        • University of Leicester

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults with non-endstage chronic kidney disease

描述

Inclusion Criteria:

  • Practice Level - all primary care practices within the 3 Clinical Commissioning Groups participating in the study.
  • Patient Level - any individual 18 years or over with an MDRD (Modification of Diet in Renal Disease) or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) eGFR (estimated glomerular filtration rate) less than 60ml/minute/1.73m2, proteinuria or a Read code CKD diagnosis.

Exclusion Criteria:

  • Aged less than 18 years of age
  • Endstage renal failure i.e. already receiving dialysis or with a kidney transplant.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cardiovascular disease events
大体时间:5 years
Major cardiovascular events, to study the natural history of CKD in a multi-ethic primary care setting and to contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD
5 years

次要结果测量

结果测量
措施说明
大体时间
全因死亡率
大体时间:5年
5年
Hospitalisation
大体时间:5 years
For individuals with CKD is associated with increased length of stay and therefore cost
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月10日

初级完成 (实际的)

2018年11月1日

研究完成 (实际的)

2018年11月1日

研究注册日期

首次提交

2017年4月19日

首先提交符合 QC 标准的

2017年4月25日

首次发布 (实际的)

2017年5月1日

研究记录更新

最后更新发布 (实际的)

2020年1月30日

上次提交的符合 QC 标准的更新

2020年1月29日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0576

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

其他的临床试验

3
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