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Safety and efficacy of remote ischaemic preconditioning in diabetic kidney disease: a pilot randomised, parallel-arm, sham-controlled trial protocol

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机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing, Peoples R China [2]Capital Med Univ, Xuanwu Hosp, Dept Nephrol, Beijing, Peoples R China [3]Capital Med Univ, Beijing Inst Brain Disorders, Beijing, Peoples R China [4]Capital Med Univ, Xuanwu Hosp, Beijing Key Lab Hypox Conditioning Translat Med, Beijing, Peoples R China [5]Capital Med Univ, Xuanwu Hosp, Neuro Cardio Vasc Dis Ctr, Beijing, Peoples R China
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关键词: Randomized Controlled Trial Clinical Protocols Diabetic nephropathy & vascular disease

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Introduction Diabetic kidney disease (DKD), characterised by rapid progression and poor prognosis, accounts for approximately 50% of all end-stage renal disease. Remote ischaemic preconditioning (RIP) can reduce the impact of subsequent fatal ischaemic events through brief episodes of ischaemia remote from a target organ. Therefore, we aim to determine whether RIP can slow the renal failure progression in patients with DKD. Methods and analysis This is a pilot randomised, parallel-arm, sham-controlled trial of 60 participants with stable DKD (chronic kidney disease stages 3-4). Participants will be randomly assigned to the intervention or control group undergoing one daily RIP or sham RIP for 3 months, with a subsequent 6-month follow-up period. The primary study outcome is the incidence of end-stage kidney disease. The secondary outcomes include changes in biomarkers of chronic kidney disease progression, cardiovascular outcomes, rates of renal failure requiring dialysis or transplantation, tolerability rates and adverse event incidence. Ethics and dissemination This study has been approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University (no. [2020]154). Our research findings will be published in peer-reviewed journal articles and conference presentations.

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大类 | 4 区 医学
小类 | 4 区 医学:内科
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大类 | 4 区 医学
小类 | 4 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL
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Q2 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing, Peoples R China
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通讯机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing, Peoples R China [3]Capital Med Univ, Beijing Inst Brain Disorders, Beijing, Peoples R China [4]Capital Med Univ, Xuanwu Hosp, Beijing Key Lab Hypox Conditioning Translat Med, Beijing, Peoples R China [5]Capital Med Univ, Xuanwu Hosp, Neuro Cardio Vasc Dis Ctr, Beijing, Peoples R China
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