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临床试验/NCT02054871
NCT02054871Unknown不适用

Randomised Controlled Trial to Evaluate the Reno-protective Benefits of Remote Ischaemic Preconditioning in Patients Undergoing Infrainguinal Peripheral Angioplasty

Mid Western Regional Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Renal impairment

研究概览

简要总结

This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal protection in patients undergoing peripheral angioplasty. Patients will be randomised to receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if any protective benefit was obtained.

详细描述

Ischaemic preconditioning is an endogenous mammalian mechanism whereby a brief period of ischaemia and reperfusion confers resistance to subsequent prolonged ischaemic insults. First observed in the canine heart, subsequent investigators noted that brief ischaemia in remote organs e.g. skeletal muscle, induced protection in key central organs e.g. the heart. This remote ischaemic preconditioning (RIPC) does not require direct interference with the target organs' blood supply. It can be induced using blood pressure cuffs to produce brief episodes of upper limb ischaemia and reperfusion and confers protection upon numerous organs simultaneously. RIPC reduces myocardial injury following aortic aneurysm repair, cardiac surgery and angioplasty. It also reduces adverse ischaemic events up to six months following percutaneous coronary intervention, implying some medium-term effect.

To date ischaemic conditioning has been applied primarily to the heart however animal studies have shown pre conditioning to offer renal protection.

Fikret et al in 2012 in the Renal Protection Trial demonstrated a protective benefit with RIPC from the development of CIN in high risk patients undergoing elective coronary angiography.Whittaker and Przyklenk in 2011 explored this concept retrospectively using data from patients who had undergone emergency angioplasty for ST elevation myocardial infarction. The original trial was a RCT which examined the protective effect of postconditioning on myocardial ischemia. The authors retrospectively examined if study patients treated with multiple coronary balloon inflations had better renal function than patients not exposed to this remote conditioning. They concluded that patients in the conditioning group received 25% more contrast volume than the control group and showed no decline in renal function as demonstrated by examination of glomular filtration rate at day 3 post procedure in comparison to the control group which saw a significant decline in renal function. The need for contrast-based procedures is rising, with increasing numbers of patients undergoing endovascular procedures, as is the incidence of postcontrast renal failure, which has a reported mortality of 34%. The potential use of RIPC therefore to reduce the risk of kidney damage needs further investigation in a prospective study and the PAD patient group who are routinely exposed to contrast administration in angiography are an ideal study group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Elective intra-arterial, infrainguinal peripheral angiography/angioplasty
  • Written informed consent
  • Patients >18yrs of age
  • Patients with CKD (Stage2/3) as evidenced by eGFR <90ml/min/1.73m2

排除标准

  • Severe renal impairment eGFR <30ml/min
  • Evidence of acute renal failure or patients on dialysis
  • History of previous CIN
  • Contraindication to intravenous volume replacement therapy
  • Pregnancy
  • Patients on glibenclamide or nicorandil (these medications may interfere with RIPC)

结局指标

主要结局

Renal impairment

时间窗: 72 hours post procedural

Serial assessment of renal biomarkers in serum and urine in 72 hour period post procedure

次要结局

  • Anti-inflammatory effect of RIPC(3-6 months post recruitment)

研究者

发起方
Mid Western Regional Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Stewart Walsh

Consultant Vascular Surgeon

Mid Western Regional Hospital, Ireland

研究点 (1)

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