RecruitingNot ApplicableNCT06501222

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

The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease: Randomized, Parallel-controlled, proof-of Concept Trial


Sponsor

Yuanjun Yang

Enrollment

114 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • CKD Patients with eGFR ≥ 15ml/min/1.73m2
  • Age ≥ 18 years old
  • hour urine protein excretion ≤ 3.5g
  • Subjects who have signed the informed consent form

Exclusion Criteria12

  • 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

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.


Locations(1)

chinese PLA general hospital

Beijing, Beijing Municipality, China

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NCT06501222


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