Effect of CPAP in the Worsening of Renal Function in Early Stages of Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- To test whether treatment with CPAP in patients with moderate to severe OSAS and CKD in stages KDIGO G1-3, reduces the progression of renal disease (30% drop in GF) after 2 years of followed up.
研究概览
简要总结
Objectives: Evaluate the effect of CPAP to reduce the progression of chronic kidney disease or CKD (the decline of glomerular filtration rate is ≥ 30%) in patients with early-stage renal disease and sleep apnea syndrome (OSAS). Other objectives are; determine the prevalence of OSAS in patients with early-stage renal disease and evaluate the changes in inflamatories markers and endothelial damage, the state of KDIGO, cardiovascular events, mortality and cost-effectiveness analysis in CPAP group versus non-CPAP group patients.
Methods: A prospective, multicentric, randomized and controlled study will be carried out for 3 years. Early-stage renal disease (G1-3 KDIGO) and OSAS patients will be included. The investigators will make a respiratory polygraphy to determinate OSAS (AHI ≥15/h) and after that, the investigators randomized patients in 2 groups; CPAP group and control group (non-CPAP treatment). Patients with AHI <15/h (non-OSAS) will be the reference group and the half of these patients, randomly chosen, will be followed up at the end of the follow up.
Statistic analysis: the investigators will analyze the differences in glomerular filtration rate before and after the treatment, comparing the percentage of patients with CKD progression for both groups. The investigators will use the chi square test with raw data and adjusted for confounding variables using intention to treat analysis with imputation of missing values.
详细描述
There is a bidirectional involvement between the chronic kidney disease (CKD) and sleep apnea syndrome (OSAS). The declining of renal function, the fluid overloading and the disturbance of ventilation control could cause sleep apneas. On the other hand, the nocturnal hypoxia in patients with OSAS has been associated with changes in the renin-angiotensin system and sympathetic nervous system and production of reactive oxygen species. These findings are relationed with the deterioration of kidney function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the outpatient nephrology department with a diagnosis of chronic kidney disease stages G1-3 KDIGO
- •Older than18 years
- •Habitual snoring or observed apneas
- •Scale sleep sleepiness (Epworth Test) with 11 points or lower.
排除标准
- •Very debilitating chronic or neoplastic disease
- •Respiratory failure (PaO 2 <55 mm Hg).
- •Other symptoms of suspected sleep disorder different from OSAS.
- •Patients unable to perform self-administered questionnaires.
- •Patients with> 50% of central apnea or Cheyne-Stokes.
- •Patients who do not sign the informed consent.
研究组 & 干预措施
cpap group
CPAP treatment plus conservative treatment with lifestyle modifications.
干预措施: CPAP (Device)
control group
Conservative treatment with lifestyle modifications.
干预措施: conservative treatment (Other)
结局指标
主要结局
To test whether treatment with CPAP in patients with moderate to severe OSAS and CKD in stages KDIGO G1-3, reduces the progression of renal disease (30% drop in GF) after 2 years of followed up.
时间窗: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Number of participants with chronic kidney disease (CKD) and obstructive sleep apnea syndrome (OSAS) with a 30% decline in estimated glomerular filtration rate (eGFR) using the CKD-EPI (CKD Epidemiology Collaboration) 2009 creatinine equation after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
次要结局
- Evaluate wheather treatment with CPAP reduces the mortality(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- Compare the percentage of patients achieving renal replacement therapy in NO OSAS group versus OSAS group(after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years))
- Evaluation of the cost-effectiveness of treatment groups with and without CPAP(after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years))
- To test whether treatment with CPAP reduces the albumin / creatinine ratio in urine.(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- To evaluate whether treatment with CPAP reduces serum Cystatin C(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- To estimate the prevalence of OSAS in patients with CKD stages G1-3 KDIGO(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- To evaluate whether treatment with CPAP reduces inflammation-endothelial disfunction markers(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- Evaluate whether treatment with CPAP reduces the progression of CKD to a different stage(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- to test wheather CPAP reduces the percentage of patients achieving replacement therapy(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- Evaluate wheather treatment with CPAP reduces the incidence of cardiovascular events(after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years))
- Compare the evolution of inflammation-endothelial disfunction markers in NO-OSAS group versus OSAS group(after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years))
- Compare the worsening of the glomerular filtration in NO OSAS group versus OSAS group(after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years))
研究者
Jaime Corral Penafiel
Principal Investigator
Sociedad Española de Neumología y Cirugía Torácica