Effect of Dexmedetomidine on Acute Kidney Injury After Ascending Aortic Surgeries: Placebo-controlled, Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- measurement of kidney function
研究概览
简要总结
Acute kidney injury (AKI) is a frequent and serious complication after ascending aortic surgeries requiring cardiopulmonary bypass (CPB). Dexmedetomidine, a selective α-2 adrenoreceptor agonist, may reduce AKI because of its sympatholytic and anti-inflammatory effects against ischaemia reperfusion injury. We investigate the effect of dexmedetomidine administration on AKI after ascending aortic surgeries requiring CPB in a placebo-controlled randomised controlled trial.
详细描述
The aim of the study is the effect of dexmedetomidine administration on AKI after ascending aortic surgeries requiring CPB in a placebo-controlled randomised controlled trial.
Type of Study: A prospective, randomized, comparative, single-center, double-blinded, interventional clinical trial study.
Study Setting: Cardiac Intensive care, Cardiac Surgical Academy Faculty of Medicine - Ain Shams University, Cairo, Egypt.
Study Period: 1 year after approval of the ethical committee of the faculty of medicine, Ain Shams University.
Study Population: 78 patients will be endorsed as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •●Age: 20-70 yrs
- •Scheduled for aortic surgery under CPB
排除标准
- •●Patient refusal to participate
- •Congestive heart failure with a left ventricular ejection fraction <45%
- •Uncontrolled arrhythmia combined with unstable hemodynamics
- •Acute coronary syndrome.
- •Preoperative elevated kidney function (serum urea and serum creatinine). Use of ventricular assist devices
研究组 & 干预措施
control arm
Group (B): the control group will receive an infusion of an equivalent volume of a 0.9% saline for the same duration
干预措施: Normal Saline (Placebo) (Drug)
active arm
Group (A): will receive Dexmedetomidine which will be mixed with 0.9% saline to achieve a concentration of 4ug/ml which will be continuously infused at a rate of 0.4 ug/kg/hr for 24 hours starting immediately after anesthetic induction
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
measurement of kidney function
时间窗: Serum creatinine levels will beassessed before surgery, at least once a day until postoperative day 5
AKI will be diagnosed based on the AKIN criteria: Stage 1 was defined as a serum creatinine increase ≥1.5-2-fold above baseline or ≥0.3 mg/dl or urine output \<0.5 ml/kg/h for \>6 h; stage 2 was defined as a creatinine increase \>2-3-fold above baseline or urine output \<0.5 ml/kg/h for \>12 h; stage 3 was defined as a creatinine increase \>3-fold above baseline or \>4.0 mg/dl with an acute increase of 0.5 mg/dl, urine output \<0.3 ml/kg/h for 24 h, or anuria for 12 h
次要结局
- inhospital mortality(perioperative)
- delirium(perioperative)