Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy controls after cardiac surgery.
In order to investigate the effect of levosimendan in patients with AKI after cardiac surgery, the investigators plan a randomized placebo controlled trial. 30 patients will receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured using infusion clearance technique of para-aminohippuric acid and Chromium ethylenediaminetetraacetic acid (Cr-EDTA) respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass
- •Acute kidney injury, defined as increase in S-creatinine 50% or 27 mol/L
- •Normal S-creatinine before surgery
排除标准
- •Ongoing treatment with inotropic drugs (not norepinephrine)
- •Central venous oxygen saturation (ScvO2) < 60% despite optimization of hematocrit and volume status
- •Need of renal replacement therapy
- •Ongoing bleeding
- •Patient or next of kin does not consent with study participation
研究组 & 干预措施
Levosimendan
Levosimendan will be given as a loading dose of 12 ug/kg during 30 minutes, and then a continuous infusion of 0,1 ug/kg/min for 180 minutes.
干预措施: Levosimendan (Drug)
Placebo
Sodium chloride will be given as a loading dose during 30 minutes and then a continuous infusion for 180 minutes at a rate mimicking the levosimendan group above.
干预措施: Placebo (Drug)
结局指标
主要结局
Glomerular filtration rate
时间窗: 5 Hours
Filtration fraction will be determined using be measured using infusion clearance technique of Chromium ethylenediaminetetraacetic acid (Cr-EDTA). Measurements will be made in duplicates before and after administration of the study drug. Glomerular filtration rate will be calculated as the filtration fraction multiplied by renal plasma flow.
Renal blood flow
时间窗: 5 Hours
Renal blood flow will be measured using infusion clearance technique of para-aminohippuric acid. Measurements will be made in duplicates before and after administration of the study drug.
次要结局
- Serum creatinine(4 days)
研究者
Lukas Lannemyr
MD
Sahlgrenska University Hospital, Sweden