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临床试验/NCT01467154
NCT01467154已完成不适用

Does Ultra-High Dose i.v. N-acetylcysteine Prevent Contrast Nephropathy in Patients With Chronic Kidney Disease Undergoing Emergency Contrast Tomography.

University Hospital, Geneva0 个研究点目标入组 124 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
主要终点
occurrence of contrast nephropathy at day 2, 4 or 10, which was defined as an increase of at least 25% and/or 44 umol/l in serum creatinine level or cystatine C levels at day 2, 4 or 10 compared to day 0.

研究概览

简要总结

The aim of the present study is to determine whether a high dose of intravenous NAC is efficient in preventing CN after emergency contrast injection in patients with renal failure.

详细描述

Prevention of acute kidney injury (AKI) post contrast injection remains mandatory given its association to morbidity and mortality1.

Contrast nephropathy (CN) was classically defined as an increase in 25% or more or absolute increase of 44 umol/l of creatinine levels within three days following contrast injection2. Markers such as cystatine C may be more sensitive to identify CN and also to correlate to mortality8 although a definition of CN using these markers is lacking.

In patients undergoing elective radiological procedures, CN can be prevented by hydration, withdrawal of diuretics and nephrotoxic drugs. N Acetylcysteine (NAC) has been proposed to protect against contrast nephropathy since 200013. While hydratation is clearly beneficial in preventing CIN14, the role of NAC administration is still uncertain and results of RCTs gave conflicting results regarding its effect15.

Intravenous N-acetylcysteine (NAC) may be the form of choice in emergency procedures given its rapid disponibility and its ease of administration in patients whose consciousness is altered or who can not eat.

The aim of the present study is therefore to determine whether 6000 mg of intravenous NAC is efficient in preventing CN after emergency contrast injection in CKD patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Renal failure and need of contrast enhanced CT

排除标准

  • Pregnancy
  • Obstructive nephropathy
  • Patient or family's refusal
  • In all patients

结局指标

主要结局

occurrence of contrast nephropathy at day 2, 4 or 10, which was defined as an increase of at least 25% and/or 44 umol/l in serum creatinine level or cystatine C levels at day 2, 4 or 10 compared to day 0.

时间窗: 10 days

次要结局

  • mean increases in creatinine and cystatin C concentrations on days 2, 4 and 10 and maximum increase during the time periods from day 2 to day 10 (peak increase).(10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Poletti Pierre-Alexandre

MD

University Hospital, Geneva

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