Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 391
- 试验地点
- 17
- 主要终点
- Death or renal replacement therapy or sustained kidney injury
研究概览
简要总结
Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for angiography
- •Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR <=44)
- •Either sex over 18 years of age
排除标准
- •Pregnant or breast feeding
- •On any kidney replacement list
- •Gastric tube in place or gastric drainage
- •Uncorrected hypoglycemia
研究组 & 干预措施
Saline infusion
Saline will be given as an active control agent to compare with sodium bicarbonate. Each bag of solution will be blinded, and given in the same manner.
干预措施: sodium bicarbonate (Drug)
Sodium Bicarbonate
Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours
干预措施: sodium bicarbonate (Drug)
结局指标
主要结局
Death or renal replacement therapy or sustained kidney injury
时间窗: Over six months following treatment
Sustained kidney injury is two sequential 20% reduction of eGFR from baseline as calculated from change in sertum creatinine at least three weeks after receiving IP.
次要结局
- A comparison between the treatments for length of hospital stay, post contrast.(Over six months after the treatment)
- A comparison between the treatments of the time to renal replacement therapy (any type) or death (whichever occurs first) over the 6-month observation period.(six months after receiving IP)