Chronic Kidney Insufficiency, Sleep Apnea
Conditions
Keywords
CPAP, Chronic kidney disease, sleep apnea
Brief summary
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.
Detailed description
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.
Interventions
DEVICECPAP
continuous positive pressure in the airway
OTHERconservative treatment
conservative treatment group with lifestyle modifications
Sponsors
Sociedad Española de Neumología y Cirugía Torácica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Number of participants with CKD and OSAS with a decline in urine albumin to creatinine ratio. |
| 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) | Number of participants with CKD and OSAS with a decline in serum cystatin C levels |
| 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) | Number of participants with CKD and OSAS with a decline in inflammation-endothelial disfunction markers (interleukine-6, interleukine-8, reactive C protein, sedimentation rate, asymmetric dimethylaginine or ADMA, intercellular adhesion molecule 1 or ICAM-1, vascular adhesion protein 1 or VCAM 1, vascular endothelial growth factor or VEGF) |
| 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) | number of participants with CKD and OSAS with a change to a higher CKD stage according to eGFR. |
| 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) | number of participants with CKD and OSAS who need renal replacement therapy (haemodialysis, peritoneal dialysis or renal transplantation) |
| 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) | Number of participants with CKD and snoring and observed apneas with an apnea and hypoapnea index (AHI) ≥15/hour in home-based polysomnography. |
| 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) | number of participants with CKD and OSAS with CPAP treatment who died (all-cause mortality) |
| 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) | Cost-effectiveness of treatment groups conducting a cost-effectiveness study that allow us to estimate the incremental cost-effectiveness ratio (ICER) of CPAP treatment group compared to the conventional treatment group |
| 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) | Number of participants with NO-OSAS versus OSAS who have a decline in inflammation-endothelial disfunction markers (interleukine-6, interleukine-8, reactive C protein, sedimentation rate, asymmetric dimethylaginine or ADMA, intercellular adhesion molecule 1 or ICAM-1, vascular adhesion protein 1 or VCAM 1, vascular endothelial growth factor or VEGF) |
| 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) | number of participants with NO OSAS versus OSAS who have a worsening of the glomerular filtration. |
| 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) | number of participants who need renal replacement therapy in NO OSAS group versus OSAS group |
| 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) | number of participants with CKD and OSAS who suffered a cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure, atrial fibrillation) |
Countries
Spain
Contacts
Primary ContactJaime Corral, MD
Backup ContactJuan F Masa, PHD
Outcome results
None listed