Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- change of creatinine level before and after cardiac surgery
研究概览
简要总结
Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Early interventions to prevent postoperative AKI can help decreasing morbidity and mortality in these patients. Using cardiopulmonary bypass during cardiac surgery triggers systemic inflammatory response and recruits pro-inflammatory cytokines such as tumor necrosis factor, interleukin -10 (IL-10) and Interleukin-6 (IL-6) accompanying with production of free oxygen radicals which provokes oxidative stress in the milieu of ischemic reperfusion injury. Pentoxifylline as a non-specific phosphodiesterase inhibitor, can suppress the production of some factors of inflammatory response and oxidative stress, probably prevent post surgery AKI with these mechanisms.
详细描述
This is a double blind randomized multicenter clinical trial, enrolling 100 consecutive patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG). Patients randomly and within concealment method divided into two groups, one to receive oral pentoxifylline 400 mg every 8 hours from three days before surgery and the other group received placebo. All the intubation , surgery and weaning protocols were the same.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
only principle investigator knew the drug from placebo
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
- •The elective CABG candidate
排除标准
- •refusal to sign the consent,
- •collagen vascular disease,
- •use of immunosuppressive agents, corticosteroids (> 3 days), methylxanthines, diltiazem or sodium nitroprusside,
- •angiography in the past 7 days,
- •hemorrhagic diathesis and coagulopathy,
- •uncontrolled diabetes mellitus
- •renal failure (sCr > 2 mg/dl),
- •hepatic failure (AST (Aspartate transaminase) or ALT(alanine transaminase) > 40 U/L)
- •urinary tract infection.
研究组 & 干预措施
placebo
50 adult patient underwent elective CABG received oral placebo pill resembling completely to pentoxifylline 400 mg, every 8 hours from three days before surgery and on the day of surgery
干预措施: Placebo (Other)
pentoxifylline oral
50 adult patient underwent elective CABG intervention to be administered will be receiving main drug (pentoxifylline )oral 400 mg' every 8 hours from three days before surgery and on the day of surgery effect of intervention regarding antioxidant
干预措施: Pentoxifylline (Other)
结局指标
主要结局
change of creatinine level before and after cardiac surgery
时间窗: change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery
change of serum creatinine level post CABG between pentoxifylline and placebo arms
次要结局
- measuring change of (BMI) weight in kilogram and height in centimeters ratio(before and after end of cardiopulmonary bypass pomp)
- Oxidative stress(before and 24 hours after end of cardiac surgery)
- inflammatory status(before and 24 hours after end of cardiac surgery)
研究者
nooshin dalili
Assistant Professor of SBMU
Shahid Beheshti University of Medical Sciences