The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease: Randomized, Parallel-controlled, proof-of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- change in eGFR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •CKD Patients with eGFR ≥ 15ml/min/1.73m2
- •Age ≥ 18 years old
- •24-hour urine protein excretion ≤ 3.5g
- •Subjects who have signed the informed consent form
排除标准
- •Patients with nephrotic syndrome
- •Patients with acute kidney injury
- •Patients who have undergone renal replacement treatment in the past
- •Patients who may have medication changes during RIC or sham-RIC intervention
- •Patients with a history of diabetes or glycated hemoglobin > 8%
- •Patients with familial hypercholesterolemia (>5.5 mmol/L) accompanied by high low-density lipoprotein (>2.5 mmol/L)
- •Patients with contraindications to RIC, such as vascular injury, soft tissue injury, fracture, infection, or known peripheral vascular disease in both arms
- •Patients with a history of hemostatic disorders, systemic bleeding, or thrombocytopenia
- •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)
- •Uncontrolled hypertension (defined as systolic blood pressure ≥ 200 mmHg despite antihypertensive treatment)
- •Patients with respiratory failure, malignant tumors, or other autoimmune diseases
- •Women who are pregnant or breastfeeding at the time of enrollment or any time during the study
结局指标
主要结局
change in eGFR
时间窗: 3 months and 12 months
eGFR is calculated using the CKD-EPI formula, eGFR in mL/min/1.73m²
次要结局
- Changes in blood pressure(3 months and 12 months)
- Changes in renal tissue oxygen saturation (SrtO2) compared to baseline.(3 months and 12 months)
研究者
Yuanjun Yang
director
Chinese PLA General Hospital