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The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

2019年9月6日 更新者：Yonsei University

Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.

The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. Agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its potential as a renoprotective agent. Furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.

The aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

108

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 大韩民国
      • Seoul、大韩民国、03722
        • Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
  2. 20 - 100 yrs old

Exclusion Criteria:

  1. having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73m2)
  2. Left ventricular-ejection fraction < 30%
  3. Preexisting congestive heart failure
  4. Severe coronary artery disease
  5. Hemodynamically unstable arrhythmia
  6. Cardiogenic shock during perioperative period
  7. Ventricular assist device use
  8. cannot communication because of a language barrier or illiteracy

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：dexmedetomidine
dexmedetomidine, 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
药品：dexmedetomidine
Immediately after the induction of anesthesia, patients in the dexmedetomidine group received dexmedetomidine continuous intravenous (IV) infusion of 0.4 mcg/kg/h until 24 hours after surgery.
安慰剂比较：control
saline, same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
药品：saline
same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
大体时间：up to 7 days after the aortic surgery
0.3 mg/dl increase in serum creatinine concentration within 48 hours OR, a 50% increase within 7 days postoperatively OR, urine volume < 0.5 ml/kg/h for 6 hours
up to 7 days after the aortic surgery

次要结果测量

结果测量
措施说明
大体时间
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
大体时间：up to 7 days after the surgery
KDIGO stage 2: Serum creatinine increase to 2-3-fold from baseline OR urine output < 0.5 ml/kg/h for 12h
up to 7 days after the surgery
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
大体时间：up to 7 days after the surgery
KDIGO stage 3: Serum creatinine increase to 3.0-fold from baseline OR Increase in serum creatinine to ≥ 4 mg/dl OR Initiation of renal replacement therapy OR In patients <18 years, decrease in eGFR to < 35 ml/min per 1.73 m2 OR Anuria for ≥ 12h.
up to 7 days after the surgery
major morbidity endpoint
大体时间：acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
acute kidney injury (same as the primary endpoint), permanent stroke, prolonged ventilator care >24h, deep wound infection, and mortality.
acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
postoperative delirium
大体时间：up to 7 days after the surgery
delirium - assessed with The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or Confusion Assessment Method for the ICU
up to 7 days after the surgery
drug-related adverse events
大体时间：hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery
hypotension (mean arterial pressure <60 mmHg) or bradycardia (<50 beats/min) OR the use of vasopressor, inotropes or temporary pacing, OR postoperative arrhythmia
hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yonsei University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年9月1日

初级完成 (实际的)

2019年3月6日

研究完成 (实际的)

2019年3月6日

研究注册日期

首次提交

2015年11月15日

首先提交符合 QC 标准的

2015年11月16日

首次发布 (估计)

2015年11月17日

研究记录更新

最后更新发布 (实际的)

2019年9月9日

上次提交的符合 QC 标准的更新

2019年9月6日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 4-2015-0672

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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