Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography
研究概览
简要总结
The investigators will study 2 separate groups:
- Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous coronary intervention).
- Patients undergoing CT examination with contrast medium. All patients will receive intravenous (I.V) hydration for 8-12h before and 36 to 48 h after angiography with 0.45% saline 100ml/h.
All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the day of the angiography and for another 48 hours.
In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo (C - control group) tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and two days after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally active haemorheological agent for the treatment of peripheral vascular disease, cerebrovascular disease and a number of other conditions involving a defective regional microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability, by reducing blood viscosity and by decreasing the potential for platelet aggregation and thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be important patho-physiological causes of contrast induced nephropathy.
详细描述
Impairment of renal function following exposure to intravenous radio-graphic contrast materials is the third major cause of renal hospital acquired renal dysfunction. Renal dysfunction occurs most often in patients with chronic renal failure and or patients with diabetes mellitus and contributes to the morbidity and mortality. Previous research work proved that the use volume expansion with N-acetyl cysteine (NAC) is superior to volume expiation alone to prevent renal impairment due to radio-contrast5. NAC a potent anti oxidant may prevent CIN by stopping direct oxidative tissue damage and by improving renal hemodynamics.Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect.Preangiographic and the highest post-angiographic values of Creatinine and eGFR (estimated glomerular filtration rate) will be recorded. Levels of the biomarker Neutrophil - gelatinase - associated lipocalin (NGAL) will be tested randomly in 49 patients p as a biomarker for contrast induced nephropathy. Blood serology for NGAL will be drown from patients before the procedure and 2 hours after angiography.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiology patients:
- •Hospitalization for ACS (acute coronary syndrome) with NSTEMI or Unstable Angina
- •Diabetic patients (treated with insulin or oral hypoglycemic drugs) or patients with basal serum creatinine greater than 1.3mg/dl in females and 1.5 mg/dl in male patients.
- •Informed consent
- •Age between 18-75
- •Radiology patients:
- •Radiology patients should be diabetic patients (treated with insulin or oral hypoglycemic drugs) or patients with basal serum creatinine of 1.3mg/dl in females and 1.5 mg/dl in male patients.
- •Informed consent
- •Age between 18-75
排除标准
- 未提供
研究组 & 干预措施
pentoxyphylline cardio
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography
干预措施: pentoxyphylline (Drug)
placebo cardio
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography
干预措施: placebo (Drug)
radiology pentoxyphylline
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast
干预措施: pentoxiphylline (Drug)
radiology placebo
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast
干预措施: placebo (Drug)
结局指标
主要结局
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography
时间窗: one year
The difference between preangiographic and postangiographic values (∆) for S.Cr and eGFR will be calculated and compared between groups. Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and levels of the biomarker Neutrophil - gelatinase - associated lipocalin (NGAL) will be tested randomly in 49 patients.contrast induced nephropathy. Comparison of the ∆ between the preangiographic and postangiographic values for S.Cr and eGFR will be performed between the groups.
次要结局
- The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in patients with elevated base line creatinin level > 2 undergoing angiography(one year)
- The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in diabetic patients undergoing angiography(one year)