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临床试验/NCT05350683
NCT05350683已完成2 期

Effect of Remote Ischemic Preconditioning on the Incidence of Contrast Induced Nephropathy in Patients Undergoing EVAR

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Incidence of contrast induces nephropathy in patients udergoing evar

研究概览

简要总结

Introduction: Contrast induced nephropathy (CIN) is a major inconvenience in the use of iodinated contrast media (ICM) and it is associated with a significant increase in morbimortality and cost of hospitalization. Remote ischemic preconditioning (RIPC) is a non-invasive and cost-effective tissular protection technique that has proven beneficial in decreasing renal insult in patients receiving intravascular contrast. Aim: The primary outcome of this study is to evaluate the impact of RIPC on the incidence of CIN in patients undergoing endovascular aneurysm repair.Material and Methods: Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media. Randomization was used to assign patients into the control/RIPC groups. Biochemical parameters determined renal function before and after surgery in immediate (24-72 hours) and at 30 days' follow-up.

详细描述

2.1. VARIABLES ANALYZED

A randomized prospective study of patients undergoing endovascular treatment for infrarenal abdominal aortic aneurysm, thoracoabdominal aortic aneurysm, descending aortic aneurysm and aneurysms of the aortoiliac sector was designed. These patients were operated at the University Clinical Hospital of Valladolid, in the period between January 2017 and January 2019. The study, which received no financial support from the industry, was performed in agreement with the Declaration of Helsinki and was approved by the institutional review board at each participating site (PI 20-1745, Valladolid East Ethics Committee for Clinical Investigation). In accordance with institutional and local regulatory policies, all patients who underwent procedures within this study signed an informed written consent.

This study only included patients scheduled for elective aortic surgery treated by endovascular repair. On the other hand, exclusion criteria were applied in patients who had peripheral artery disease in the upper limbs, chronic kidney disease grade V on replacement therapy with haemodialysis, patients with cardiac decompensation at the time of the intervention and those who did not tolerate the preparation by ischemic preconditioning in the non-dominant upper limb or who refused to participate in the study.

The variables studied were age and gender, personal history of arterial hypertension, diabetes mellitus, chronic kidney disease and congestive heart failure, levels of estimated glomerular filtrate with the CKD-EPI formula, drugs that may affect renal function such as nephrotoxic medication (metformin, NSAIDs, aminoglycosides, glibenclamide or others) and drugs that can modify renal response to iodinated contrast (n-acetylcystein or sodium bicarbonate) and laboratory values: preoperative serum albumin creatinine, urea, hematocrit and urinary albumin/creatinine ratio in the preoperative period, at 24h and 48h of the administration of iodinated contrast and one month after the administration of iodinated contrast. Volume of iodinated contrast used, intraoperative serum therapy and during admission, type of endograft used, anesthetic technique, intraoperative drugs and in the immediate postoperative period and diuresis in the first 24h was also noted. The impact of preconditioning was measured in terms of absolute and relative creatinine variation in the first 48h according to the definition of contrast nephropathy detailed in section 1.

2.2. NEPHROPROTECTION PROTOCOL

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
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients scheduled for elective aortic surgery treated by endovascular repair

排除标准

  • peripheral artery disease in the upper limbs
  • chronic kidney disease grade V on replacement therapy with haemodialysis, - - patients with cardiac decompensation at the time of the interventio
  • those who did not tolerate the preparation by ischemic preconditioning in the non-dominant upper limb or who refused to participate in the study.

结局指标

主要结局

Incidence of contrast induces nephropathy in patients udergoing evar

时间窗: 30 days

serum creatinine

次要结局

  • Other variables(30 days)

研究者

发起方
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
申办方类型
Network
责任方
Sponsor

研究点 (1)

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