The Role of Pentoxifylline for Prevention of Contrast Induced Nephropathy in Chronic Kidney Diseased Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of contrast induced nephropathy
研究概览
简要总结
The aim of this study is to evaluate the effect of pentoxifylline for control of contrast induced nephropathy in chronic kidney diseased patients in intensive care unit.
详细描述
Contrast-induced acute kidney injury (AKI), which is also known as contrast-induced nephropathy (CIN), is defined as the development of AKI following contrast medium exposure, without an alternative aetiology.
Recently, the cyclic nucleotide phosphodiesterase (PDE) has emerged as a promising target for pharmacological intervention against chronic kidney disease (CKD) progression.
The nonselective PDE inhibitor pentoxifylline (PTX) is a methyl xanthine derivative. It's an old drug that exhibits prominent anti-inflammatory, anti-proliferative and anti-fibrotic activities both in vitro and in vivo. In addition to its classic indication for intermittent claudication. It has been used primarily to treat patients with peripheral arterial insufficiency.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •Both sexes.
- •The presence of chronic kidney disease (CKD) is defined according to the National Kidney Foundation-kidney disease Outcomes Quality Initiative guidelines with second or third stage.
- •Urgent patients expected taking dye in stable cases of cardiac catheterization or pulmonary embolism with Geneva score (4-11).
排除标准
- •Patients with CKD on renal replacement therapy.
- •Respiratory failure.
- •Cardiac failure.
- •Liver failure.
- •Methylxanthines hypersensitivity.
研究组 & 干预措施
Group I
Patients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure.
干预措施: Pentoxifylline (Drug)
Group II
Patient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure.
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of contrast induced nephropathy
时间窗: 48 hours after contrast procedure.
Incidence of contrast induced nephropathy was recorded.
次要结局
- Progress of glomerular filtration rate(48 hours after contrast procedure.)
- Lenght of intensive care unit stay(Till the end of procedure (Up to 4 hours))
- Need of dialysis(48 hours after contrast procedure.)
研究者
Alaa Samy Mohamed Mostafa
Resident of Anesthesiology Surgical Intensive Care and Pain Management, Tanta University, Tanta, Egypt.
Tanta University