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临床试验/NCT04215042
NCT04215042Unknown不适用

Prevention of Contrast-Induced Acute Kidney Injury: Standard Versus Short Hydration Protocol in Patients With Normal Fluid Status Assessed by the Bioimpedance Analysis (The HYDRA II Study)

Ospedale Misericordia e Dolce1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
incidence of contrast induced acute kidney injury (CI-AKI)

研究概览

简要总结

The aim of this study was to evaluate, in patients with "normal fluid status" assessed by the bio-impedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for Contrast Induced Acute Kidney Injury in patients undergoing coronary angiographic procedure.

详细描述

Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI). Extracellular volume expansion at the time of contrast media administration may represent important protective strategies that play a major role in the prevention CI-AKI.

Bio-impedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes [Maioli, Journal of American College Cardiology 1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/ height ratio > 315 Ohm/meter and Female > 380 Ohm/meter). Bio-impedance analysis IVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.

Infusing a standardized amount of fluid before the procedure may not result in the same effects in all patients. Moreover, standardized fluid infusion for 24 hours in patients that present with "normal fluid status" assessed by the bioimpedance analysis, can represent a too expensive preventive option both in terms of care and discomfort for the patient. In this study we analyze the possibility of a non-inferiority preventive protocol that involves a lower infusion of saline solution with a shorter administration time.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "normal fluid status" assessed on the basis bio-impedance analysis (Male with resistance/height ratio < 315 Ohm/meter and female < 380 Ohm/meter)

排除标准

  • contrast medium administration within the 10 days
  • end stage renal failure requiring dialysis
  • no ability to evaluation the state of hydration with bio impedance
  • refused to give informed consent

研究组 & 干预措施

Standard hydration

Active Comparator

All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure

干预措施: sodium chloride infusion (Drug)

Short hydration

Experimental

All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)

干预措施: sodium chloride infusion (Drug)

结局指标

主要结局

incidence of contrast induced acute kidney injury (CI-AKI)

时间窗: 1 day

CI-AKI is defined as an increase in serum Cystatin C concentration 10%, above the baseline value, at 24 hours after administration of contrast medium

次要结局

  • incidence of contrast induced acute kidney injury (CI-AKI)(2 days)

研究者

发起方
Ospedale Misericordia e Dolce
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Maioli

Medical Doctor - Cardiology

Ospedale Misericordia e Dolce

研究点 (1)

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