The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Device: Remote ischemic conditioning

• Registration Number: NCT06501222
• Lead Sponsor: Yuanjun Yang

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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-06-16
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2026-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham-RIC group	Remote ischemic conditioning	The sham-RIC protocol involves five cycles of alternating inflation of both upper arms, utilizing an automated device to alternately inflate to 60 mmHg for 5 minutes and deflate for 5 minutes.
RIC group	Remote ischemic conditioning	The RIC protocol involves five cycles of alternating inflation of both upper arms, utilizing an automated device to alternately inflate to 200 mmHg for 5 minutes and deflate for 5 minutes.

Primary Outcome Measures

Name	Time	Method
change in eGFR	3 months and 12 months	eGFR is calculated using the CKD-EPI formula, eGFR in mL/min/1.73m²

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure	3 months and 12 months	blood pressure in mmHg
Changes in renal tissue oxygen saturation (SrtO2) compared to baseline.	3 months and 12 months	SrtO2 is measured by Near Infrared Spectroscopy

Trial Locations

Locations (1)

chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China