Chronic Kidney Diseases
Conditions
Keywords
remote ischemic conditioning, chronic kidney disease, renal function
Brief summary
The incidence of Chronic kidney disease (CKD) is showing an upward trend, but the therapeutic effect of treatment is limited. Remote ischemic conditioning (RIC) has the potential to safeguard remote organs via the repeated application of brief ischemic stimuli. the aim of our study is to investigate whether RIC can protect the renal function in patients with CKD.
Detailed description
Chronic kidney disease (CKD) is characterized by progressive and irreversible loss of nephrons. Currently, due to the increasing prevalence of diabetes, hypertension, obesity, and the impact of population aging, the incidence of CKD is showing an upward trend. The treatment of CKD is mostly aimed at delaying the progression of renal function, but the therapeutic effect is limited, causing a continuous economic burden for CKD patients. Therefore, there is an urgent need to develop new treatment methods to prevent or reverse the progression of the disease. Remote ischemic conditioning (RIC) is a process that involves repeatedly applying brief ischemic stimuli to a certain organ or tissue, which stimulates the body's endogenous anti-ischemic injury ability, enabling other organs or tissues besides the stimulated one to adapt to ischemia and improve their tolerance to ischemic injury, thereby reducing the damage caused by ischemia to relevant organs or tissues. Current studies have confirmed that RIC can protect remote organs such as the heart, brain, and kidneys through multiple pathways, including humoral mechanisms, neural conduction regulation mechanisms, and immune inflammatory regulation mechanisms. However, current research in the field of kidney diseases has been mostly limited to acute kidney injury caused by contrast agents, surgery, etc., and there are no reports on the intervention and treatment of CKD patients using RIC. Therefore, exploring whether RIC can delay the progression of renal function in CKD patients is of great significance.
Interventions
DEVICERemote ischemic conditioning
RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Sponsors
Yuanjun Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. CKD Patients with eGFR ≥ 15ml/min/1.73m2 2. Age ≥ 18 years old 3. 24-hour urine protein excretion ≤ 3.5g 4. Subjects who have signed the informed consent form
Exclusion criteria
1. Patients with nephrotic syndrome 2. Patients with acute kidney injury 3. Patients who have undergone renal replacement treatment in the past 4. Patients who may have medication changes during RIC or sham-RIC intervention 5. Patients with a history of diabetes or glycated hemoglobin \> 8% 6. Patients with familial hypercholesterolemia (\>5.5 mmol/L) accompanied by high low-density lipoprotein (\>2.5 mmol/L) 7. Patients with contraindications to RIC, such as vascular injury, soft tissue injury, fracture, infection, or known peripheral vascular disease in both arms 8. Patients with a history of hemostatic disorders, systemic bleeding, or thrombocytopenia 9. Patients with cardiogenic embolism (atrial fibrillation) or other severe arrhythmias (severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia), previous myocardial infarction, or severe heart failure (New York Heart Association Class III and IV) 10. Uncontrolled hypertension (defined as systolic blood pressure ≥ 200 mmHg despite antihypertensive treatment) 11. Patients with respiratory failure, malignant tumors, or other autoimmune diseases 12. Women who are pregnant or breastfeeding at the time of enrollment or any time during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in eGFR | 3 months and 12 months | eGFR is calculated using the CKD-EPI formula, eGFR in mL/min/1.73m² |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in renal tissue oxygen saturation (SrtO2) compared to baseline. | 3 months and 12 months | SrtO2 is measured by Near Infrared Spectroscopy |
| Changes in blood pressure | 3 months and 12 months | blood pressure in mmHg |
Other
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urine protein quantitation compared to baseline. | 3 months and 12 months | The 24-hour urine protein quantitation is monitored through urine. |
| change in Pulse Wave Velocity compared to baseline. | 3 months | brachial-ankle Pulse Wave Velocity in cm/s |
| change in Flow-mediated vasodilation compared to baseline. | 3 months | FMD in % |
Countries
China
Contacts
Primary ContactYisha Li, PhD
Backup ContactDayang Xie, PhD
Outcome results
None listed