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临床试验/NCT02444013
NCT02444013Unknown4 期

Periprocedural Administration of Folic Acid for Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary CTA/Angiography/Angioplasty

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
400
试验地点
1
主要终点
Occurrence of contrast-induced nephropathy

研究概览

简要总结

The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.

详细描述

Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.

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
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Inpatients undergoing coronary CTA/angiography/angioplasty

排除标准

  • exposure to nephrotoxic drugs prior to or during the study period
  • end-stage renal failure requiring dialysis
  • allergy to iodine-containing contrast medium
  • pregnancy
  • refusal to give informed consent

研究组 & 干预措施

Folic acid

Active Comparator

Oral folic acid (5 mg, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

干预措施: Folic acid (Drug)

Placebo

Placebo Comparator

Oral placebo (1 tablet, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

干预措施: Placebo (Drug)

结局指标

主要结局

Occurrence of contrast-induced nephropathy

时间窗: Within 48 hours after contrast exposure

Contrast-induced nephropathy is defined as an elevation of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours after contrast exposure

次要结局

  • Major in-hospital clinical events, including death and need for dialysis or hemofiltration(participants will be followed for the duration of hospital stay, an expected average of 10 days)

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinlai Liu

Professor

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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