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临床试验/NCT03709264
NCT03709264已完成3 期

Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery: a Multi-centre Randomized Blinded Placebo Controlled Clinical Trial.

Università Vita-Salute San Raffaele22 个研究点 分布在 3 个国家目标入组 3,511 人开始时间: 2019年10月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
3,511
试验地点
22
主要终点
AKI incidence

研究概览

简要总结

To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino acids (Woods LL 1993) mediated by a afferent arteriolar dilation.(Meyer TW 1983) Moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. Finally, these nephro-protective effects are preserved in critical illness. Cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. Although the etiology of AKI in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. In this setting, a global increase in renal blood flow by means of Amino Acid therapy appears a logical and promising intervention.

The primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (AKI) in patients scheduled for cardiac surgery defined as KDIGO stage 1 or greater during hospital stay.

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, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • scheduled cardiac surgery
  • expected to stay in ICU at least 1 night after surgery
  • signed informed consent

排除标准

  • Patient currently enrolled into another randomized clinical trial
  • Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy
  • Patients with CKD of equal or more than CKD stage IV (GFR<30 ml/min/1.73 m2)
  • Patient with a kidney transplant
  • Patient is not expected to survive ICU or hospital discharge
  • Patient previously been enrolled and randomized into this study
  • Patient has severe liver disease (Child-Pugh score >7 points)
  • Patient has a hypersensitivity (known allergy) to one or more of the included amino acids
  • Patient has a congenital alteration of amino acid metabolism
  • Pregnant or currently breastfeeding patients
  • Patients with any of the contraindications reported in the summary product characteristics.

研究组 & 干预措施

Amino Acids infusion

Experimental

干预措施: Amino Acids (Drug)

Placebo

Placebo Comparator

干预措施: Placebos (Drug)

结局指标

主要结局

AKI incidence

时间窗: Until hospital discharge, an average of 10 days

Incidence of Acute Kidney Injury during hospital stay

次要结局

  • Mortality(180 days)
  • RRT(180 days)
  • ICU stay(Until ICU discharge, an average of 2 days)
  • Hospital stay(Until hospital discharge, an average of 10 days)
  • Mechanical Ventilation(Until ICU discharge, an average of 2 days)
  • EQ-5D(180 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Landoni

MD, Associate Professor

Università Vita-Salute San Raffaele

研究点 (22)

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