New Diagnostic System for the Early Detection of Chronic Renal Damage Associated to Tobacco Consumption: Preventive and Personalized Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change of urinary N-Acetyl-β-D-Glucosaminidase (NAG)
研究概览
简要总结
Tobacco consumption is associated with the appearance of several pathologies, the best known are Chronic Obstructive Pulmonary Disease, several types of cancer and cardiovascular diseases. However, the association between tobacco and kidney damage is not well defined. Some studies suggest that smoking favors progression to chronic kidney disease (CKD). CKD does not have pharmacological treatment and the only clinical strategies useful so far are dialysis or kidney transplantation. Therefore, knowing if tobacco is involved in this disease is a very relevant fact, since it is a modifiable factor. Of all the risk factors associated with the onset and progression of kidney disease is the only one that can be avoid or eliminated. Therefore quitting smoking could help reduce the incidence of this pathology.
In this project, 3 main objectives were proposed:
- First: to study the tobacco-CKD association in a more exhaustive way. In a population group (patients who attend a primary care center) the renal function of smokers will be evaluated, comparing it with that of non-smokers with similar characteristics (age, sex, etc). In addition, the presence of certain pathologies that can affect the kidney (diabetes mellitus, hypertension and / or frequent consumption of certain medications) will be taken into account. To evaluate the renal functionality, the markers commonly used in the clinic and other more novel ones will be used (urinary biomarkers of early kidney damage).
- Second: to assess whether smoking patients will be more likely to suffer kidney damage in the future. This will be done by monitoring the patients mentioned above, for two years. During this time, a group of novel markers (urinary biomarkers of predisposition to kidney damage) that in previous studies have detected susceptibility to kidney damage will be evaluated. It will be determined which one or more of these markers are capable of predicting at time 0 (when the first sample of the patient is taken) the subsequent appearance of renal damage.
- Third: to study whether stopping smoking reduces the risk of developing CKD. It will be evaluated whether stopping smoking reduces the susceptibility to kidney damage by using the biomarkers mentioned above.
详细描述
According to the WHO, smoking is the main cause of preventable disease and death, being a known risk factor for the development of cancer, respiratory diseases, cardiovascular diseases, etc. Despite the fact that the first associations between smoking and kidney disease date back to the beginning of the last century, up to the present time, evidence has been scarce and inconclusive in the population without risk factors associated with kidney disease.
The increase in the worldwide prevalence of chronic kidney disease and the notable increase in the incidence of patients reaching the final stage of the same, have alerted health systems and have determined that nephrologists focus more on the identification of potentially modifiable prevention factors. Chronic kidney disease has a very high social and economic cost (almost 10% of the affected population and 3% of total health expenditure), which requires coordinated criteria among health professionals to ensure the best levels of quality in prevention, diagnosis and treatment. In this sense, it is recognized that the key to preventive success is a very early diagnosis that allows intervention when the renal functional reserve has not yet been exhausted and, therefore, the excretory function is not yet compromised. In the clinic, one of the most used tools in the diagnosis of kidney damage is based on the detection in the blood of products of metabolism (creatinine, urea, etc.) that begin to accumulate once the renal excretory capacity begins to decrease. However, when the increase in serum urea and creatinine levels is observed, more than 70% of renal function has been lost. Thus, current trends in diagnosis seek to find sensitive markers, specific, and easy to quantify, that detect incipient pathophysiological events produced in early stages, when the damage is less widespread.
To evaluate in depth the association between tobacco consumption and kidney damage, as well as the capacity to recover renal function after cessation of consumption, a longitudinal prospective observational study is proposed. Participants will be informed of the objectives of the project and its benefits both verbally and in writing and will have to sign an informed consent in accordance with the Declaration of Helsinki and the WHO standards for observational studies. Patients will be included completely anonymously and their data will be treated confidentially according to the current data protection legislation. Patients may withdraw freely from the study at any time.
In this study, three main objectives have been proposed:
OBJECTIVE 1: To detect subclinical renal damage in smokers through a battery of early markers.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of legal age who agree to participate in the study and do not comply with any of the exclusion criteria
排除标准
- •Patients who are terminally ill; presenting previously diagnosed renal failure
- •Patients that during the week prior to the sample collection, or at the time of the sample, have been treated with any of the following drugs: aminoglycosides, cephalosporins, tetracyclines, amphotericin B, cisplatin, cyclosporine, foscarnet, acyclovir, cidofovir, radiological contrasts or any other potentially nephrotoxic drug.
- •Patients who do not wish to sign the informed consent
结局指标
主要结局
Change of urinary N-Acetyl-β-D-Glucosaminidase (NAG)
时间窗: For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months
It is an enzyme whose urinary excretion is elevated in case of kidney damage. It is capable of detecting damage before the classic plasma creatinin and urea markers. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.
Change of urinary T-gelsolin.
时间窗: For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months
It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups.This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.
Change of urinary albumin
时间窗: For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months
It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.
Change of urinary Kidney Injury Molecule-1 (KIM-1)
时间窗: For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months
It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.
Change of urinary Neutrophil gelatinase-associated lipocalin (NGAL)
时间窗: For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months
It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.
Change of urinary biomarkers of predisposition to kidney injury
时间窗: For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months
It is a group of markers that are in patent phase so their names can not be mentioned. They are able to detect the susceptibility to kidney damage before administering a nephrotoxic agent. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.
次要结局
- Percentage of patients with Risk factor's(These data will be collected once, at time 0 (moment of inclusion in the study))
- Concentration of plasma urea(These data will be collected once, at time 0 (moment of inclusion in the study))
- Lung capacity(These data will be collected once, at time 0 (moment of inclusion in the study))
- Body weight(These data will be collected once, at time 0 (moment of inclusion in the study))
- Concentration of plasma creatinine(These data will be collected once, at time 0 (moment of inclusion in the study))
- Body mass index (BMI)(These data will be collected once, at time 0 (moment of inclusion in the study))
- Sex(These data will be collected once, at time 0 (moment of inclusion in the study))
- Height(These data will be collected once, at time 0 (moment of inclusion in the study))
- Age(These data will be collected once, at time 0 (moment of inclusion in the study))
- Quantitative determination of tobacco consumption(For objectives 1 and 2: 0 and 24 months. For the objective 3: 0, 3, 6 and 12 months.)