Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of nephrotoxicty
研究概览
简要总结
A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.
详细描述
Critically ill patients who have gram positive infection (MRSA) and need vancomycin will be assigned randomly into two groups. The first group will be given vancomycin intravenous only (15-20 mg/kg) every 8-12 hours , while the second group will take vancomycin intravenous (15-20 mg/kg) every 8-12 hours plus ascorbic acid 1 gram twice daily orally just before the vancomycin administration by half an hour. Patients will be monitored for one week where serum creatinine, BUN, urine output, trough level will be measured. Acute kidney injury will be determined according to RIFLE criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are critically ill and with MRSA infection suspection.
排除标准
- •Pregnancy or breast feeding.
- •Known allergy to either vancomycin or ascorbic acid.
- •Base line serum creatinine ≥2mg/dl.
- •Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors).
- •Anticepated administration of contrast medium within 7 days.
- •Patients suffering from some underlying diseases (e.g., cancer, HIV infection, systemic lupus erythematoses,or urinary tract stones).
- •Unlikelyhood of receiving the study medications for at least 72 hours
研究组 & 干预措施
Vancomycin +Ascorbic acid
Vancomycin 15-20mg/kg intravenous every 8-12 hours. Ascorbic acid 1gm every 12 hours orally just before vancomycin by half an hour for seven days.
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Incidence of nephrotoxicty
时间窗: one week
Incidence of nephrotoxicty will be described according to RIFLE criteria
次要结局
- 28 days Mortality(one month)
研究者
Nouran Hesham Ali
clinical pharmacist at the critical care medicine unit- Cairo university hospitals
Ain Shams University