Influence of Fenoldopam and Ketanserin on Function and Kidney Injury Parameters in Patients With Increased Risk of Acute Kidney Failure After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cystatin C and NGAL in serum
研究概览
简要总结
The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.
详细描述
Informed, signed consent will be obtained from the patient before surgery. In patients with acute consciousness disorders, the consent will be obtained from a legal representative and confirmed by the local court - accordingly to Polish legacy.
Patients willing to participate into the study and fulfilling at least one of two inclusion criteria will be randomly assigned to one of the three study groups. The treatment will be applied for 24 hours.
Intention to treat analysis will include comparison for differences of continuous, homogeneous distributed data with use of parametric tests, parametric or inhomogeneous distributed data - with use of nonparametric tests. The treatment effect will be assessed by comparison of the odds ratios for primary and secondary outcomes between the groups.
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, Care Provider)
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
- •cardiac surgery
- •at least one risk factor for acute renal failure:
- •oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously
- •at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour
排除标准
- •refused or none consent
- •chronic renal failure with chronic renal replacement therapy
- •chronic increase of serum creatinine > 2 mg/dl
研究组 & 干预措施
Placebo
Control group receiving placebo
干预措施: placebo (Drug)
Ketanserin
patients receiving ketanserin infusion
干预措施: ketanserin (Sufrexal) (Drug)
Fenoldopam
patients receiving fenoldopam infusion
干预措施: fenoldopam (Corlopam) (Drug)
结局指标
主要结局
cystatin C and NGAL in serum
时间窗: after 24 and 48 hours from treatment start
次要结局
- β2microglobulin in urine(after 24, 48 and 72 hours of treatment)
- frequency of renal replacement therapy(7 days after surgery)
- creatinine increase in serum(after 24, 48 and 72 hours of treatment)
研究者
Maciej M. Kowalik
Dr.
Medical University of Gdansk