To Evaluate if Dexmedetomidine Infusion Has a Role in Renal Protection in Patients Undergoing Coronary Artery Bypass Graft Surgery. A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post CABG Acute Kidney Injury at 48 hours
研究概览
简要总结
OBJECTIVE: Aim of this study is to follow and compare the changes in serum creatinine and urine output up to 48 hours of surgery in patients receiving dexmedetomidine infusion in addition to standard protocol (Experimental Group) as compared to the patients receiving standard protocol alone. (Control Group) in patients undergoing isolated coronary artery bypass grafting surgery (CABG) at a tertiary care cardiac center of Karachi, Pakistan.
STUDY DESIGN: Randomized control trial
PLACE & DURATION OF STUDY: The research will be conducted in the Department of Anesthesia & Intensive Care, National Institute of Cardiovascular Diseases (NICVD), Karachi. 6 months (01/08/2021 to 31/1/2022).
DATA COLLECTION PROCEDURE: This study was conducted among 60 patients allocated randomly into two groups. In the study group (group D), dexmedetomidine was given as an infusion of 0.4 μg/kg/h from induction of anesthesia for 24 hours. In the control group (group C), the patients were receiving an equal volume of normal saline.
PRIMARY OUTCOME: The primary outcome of the study was Serum Creatinine (mg/dl) which was measured before the surgery at baseline and then 48 hours after surgery.
SECONDARY OUTCOMES: The secondary outcomes were incidence of urine output per hour for up to 48 hours after surgery, operative time from induction of anesthesia till skin closure, aortic cross-clamp time from application of aortic cross-clamping till aortic declamping, CPB time from connecting the patient to extracorporeal circulation till termination of CPB, duration of ICU stay from transferring the patient from the operating room to the ICU till patient discharge to the ward, episodes of bradycardia and hypotension, dosage of inotropics and hemoglobin levels at baseline and up to 48 hours.
KEYWORDS: cardiac surgery-associated acute kidney injury, dexmedetomidine, serum creatinine.
详细描述
INTRODUCTION:
The incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) varies from 5 to 42%.1 This percentage was found to be 7.86% according to study conducted in Pakistan. 2 Severe CSA-AKI is independently associated with three to eight-fold higher perioperative mortality, prolonged ICU and hospital length of stay, and increased cost of care.3 The etiology of renal injury is mainly due to elevation of renin levels as a result of sympathetic overactivity in addition to nephrotoxic inflammatory and hemodynamic components.4 The risk risk factors, even for those patients with complete renal recovery.3 As yet, there is no definite strategy for preventing AKI after cardiac surgery.5
Dexmedetomidine is a selective and potent α2-adrenoceptor agonist that is used for its anxiolytic, sedative, and analgesic properties.6 It decreases central nervous system sympathetic outflow in a dose-dependent manner and has opioid-sparing analgesic effects. There is increasing evidence of its organ-protective properties against ischemic and hypoxic injury, including cardioprotection, neuroprotection, and renoprotection.7,8 Peng et al. in his meta-analysis has highlighted the significant role of dexmedetomidine in reducing AKI after bypass surgeries.8 Then, R.Shi and H-T. Toe have also pointed out the promising renoprotective role of Dexmedetomidine in CABG surgeries. 10 Kidney Disease Improving Global Outcomes (KDIGO) is one of the latest classifications of identifying AKI and is commonly used in various studies. 11 In 2016, Ammar AS et al. in their study documented the reno-protective role of peri-operative dexmedetomidine infusion in cardiac surgery.4 The aim of this study is to use infusion of dexmedetomidine for renal protection in cardiac surgeries.
PATIENTS AND METHODS:
The aim of this study was to compare the changes in serum creatinine and urine output up to 48 hours of surgery in patients receiving dexmedetomidine infusion in addition to standard protocol as compared to the patients receiving standard protocol alone, and see if dexmedetomidine infusion reduced the incidence of Acute Kidney Injury (AKI) in patients undergoing coronary artery bypass graft surgery (CABG) in a tertiary cardiac center of Karachi, Pakistan. This study, a randomized control trial, was conducted in the Department of Anesthesia & Intensive Care, National Institute of Cardiovascular Diseases (NICVD), Karachi, for a period of 6 months (01/08/2021 to 31/1/2022), after approval from the ethical review committee of NICVD, Karachi.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages ranged between 18 and 65 years.
- •Patients undergoing isolated coronary artery bypass grafting.
- •Class II and III ASA physical status.
排除标准
- •Patients with preoperative renal impairment (elevated creatinine and blood urea nitrogen levels) and diuretic use.
- •Preexisting hepatic or pulmonary disease, peripheral vascular disease, previous cardiac surgery, emergency surgery, reopening surgeries, surgeries requiring a deep hypothermic circulatory arrest.
- •Preoperative use of inotropes or vasopressors.
- •Perioperative use of diuretics.
- •Perioperative episode of CPR.
- •Diabetic patients.
- •Preoperative hemoglobin level less than 12 mg/dl.
- •Hematological disorders.
- •Morbidly obese patients.
研究组 & 干预措施
Group D
Dexmedetomidine was given as an infusion of 0.4 μg/kg/h from induction of anesthesia for 24 hours.
干预措施: Dexmedetomidine (Drug)
Group C
Equal volume of normal saline.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Post CABG Acute Kidney Injury at 48 hours
时间窗: up to 48 hours post operatively
Serum Creatinine (milligram/decilitre) as Kidney Disease Improving Global Outcomes criteria
次要结局
- Amount of Urine(up to 48 hours)
- Aortic Cross Clamp Time(within 2 hours)
- CPB Time(within 4 hours)
- Time of Surgery(within 8 hours)
- ICU stay(up to 48 hours)
研究者
Haris Tariq
Post Fellow
National Institute of Cardiovascular Diseases, Pakistan