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临床试验/NCT05268562
NCT05268562进行中(未招募)4 期

Impact of Ketamine Versus Propofol for Anesthetic Induction on Acute Kidney Injury and Renal Biomarkers in Cardiac Surgery

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
Mayo Clinic
入组人数
200
试验地点
1
主要终点
Acute Kidney Injury

研究概览

简要总结

The purpose of this study is to investigate the affects of ketamine use for anesthesia at the beginning of heart surgery on kidneys compared to the use of propofol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
  • •Scheduled to undergo complex cardiac surgery with the use of cardiopulmonary bypass. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and coronary artery bypass graft procedures (aortic repair not excluded if meets other criteria).

排除标准

  • •Left or right ventricular assist device implantation or explantation.
  • •Procedures not requiring cardiopulmonary bypass.
  • •Active infection or sepsis requiring antimicrobial therapy and/or vasopressor therapy (treated endocarditis is not excluded).
  • •Severe hepatic disease resulting in ascites.
  • •Pre-operative significant renal dysfunction including a baseline creatinine equal to or greater than 2 mg/dL or requiring dialysis.
  • •Immunosuppressive medication use (including current IV or oral steroids use, use of anti-rejection medications for transplant within 1 month, or chemotherapy within 6 months).
  • •Immunodeficiency syndrome including HIV/AIDS, leukemia, and multiple myeloma

研究组 & 干预措施

Anesthesia induction with Propofol

Active Comparator

Subjects will receive Propofol to begin anesthesia for their cardiac surgery.

干预措施: Propofol (Drug)

Anesthesia induction with Ketamine

Active Comparator

Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.

干预措施: Ketamine (Drug)

结局指标

主要结局

Acute Kidney Injury

时间窗: Immediately postop up to 10 days postoperatively

The incidence of acute kidney injury in patients following cardiac surgery

次要结局

  • Vasopressor use(Immediately post induction up to 30 minute following induction)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erica D. Wittwer, M.D., Ph.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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