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临床试验/NCT06248359
NCT06248359已完成不适用

Association Between Early Postoperative L-Arginine Administration and Acute Kidney Injury Following Cardiac Surgery

Xijing Hospital2 个研究点 分布在 1 个国家目标入组 5,135 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,135
试验地点
2
主要终点
incidence of postoperative AKI

研究概览

简要总结

To investigate the association between the the early administration of L-Arginine after CPB-assisted cardiac surgery and the incidence of CS-AKI in adult patients. To test if it can reduce the incidence of post-operative AKI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • adult patients (over 18 years)
  • underwent CPB assisted cardiac surgery
  • admitted to ICU

排除标准

  • congenital heart disease
  • underwent deep hypothermic circulatory arrest (DHCA)
  • with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²

研究组 & 干预措施

Without Arginine

No L-arginie was administered

Arginine Use

At least one dose of L-arginie was administered in the early postoperative stage

干预措施: L-Arginine hydrochloride (Drug)

结局指标

主要结局

incidence of postoperative AKI

时间窗: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days

Serum Creatinine Criteria: Increase in Serum Creatinine: An absolute increase in serum creatinine of 0.3 mg/dL (26.5 µmol/L) within 48 hours. OR a percentage increase in serum creatinine of ≥50% within 7 days. These criteria are relative to the baseline creatinine level, which is usually the recent preadmission value. Urine Output Criteria: Oliguria, defined as a urine output \<0.5 mL/kg/h for more than 6 hours. OR anuria, defined as a urine output \<100 mL in 24 hours.

次要结局

  • length of in-hospital stay(from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days)
  • Renal failure(from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days)
  • in-hospital mortality(from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chong Lei, MD & phD

Principal Investigator

Xijing Hospital

研究点 (2)

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