The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in serum creatinine (SCr)
研究概览
简要总结
This clinical trial aims to evaluate the effect of dexmedetomidine in Sepsis-Associated Acute Kidney Injury in critically ill patients by answering the following questions:
- What is dexmedetomidine's effect on kidney functions?
- What is the safety and efficacy of dexmedetomidine in Sepsis-Associated Acute Kidney Injury?
The investigator will compare dexmedetomidine to the standard sedative.
The Participant will take either dexmedetomidine or the standard sedative during their hospitalization, with follow-up of the following:
- Vital signs including blood pressure, body temperature, respiratory rate, heart rate, and oxygen saturation.
- Laboratory data including kidney function tests, electrolytes, complete blood count, and liver function tests.
- An electrocardiogram will be followed to check the heart's electrical activity.
- The level of alertness or agitation to avoid over and under-sedation.
- The level of organ dysfunction and mortality risks.
- Duration of mechanical ventilation.
- Duration of hospitalization.
详细描述
Recently, it has been confirmed that dexmedetomidine has an organ protective effect, including the nervous system, heart, lungs, kidneys, liver, and small intestine. These properties allow dexmedetomidine to be a promising candidate for clinical multiorgan protection.
Aim of the study: Evaluation of the effect of dexmedetomidine in Sepsis-Associated Acute Kidney Injury (SA-AKI).
Objectives:
- Assessment of dexmedetomidine effect in SA-AKI through following serum creatinine (SCr) level, urinary output (UOP), and the need for renal replacement therapy (RRT).
- Assessment of dexmedetomidine safety in SA-AKI through following the incidence of new-onset bradycardia, and hypotension requiring intervention.
- Assessment of dexmedetomidine efficacy by determining the effect on hospital mortality, duration of mechanical ventilation (MV), days free of agitation, incidence of organ dysfunction other than AKI, and length of hospital and ICU stay.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Patients with sepsis who develop AKI within 48 hours during ICU stay
- •Need for sedation due to the need for mechanical ventilation (MV) (both invasive and non- invasive) within 48 hours of AKI
排除标准
- •Contraindications to dexmedetomidine including any of the following: severe bradycardia (heart rate (HR) < 50 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block unless a pacemaker is inserted
- •Acute myocardial ischemia
- •Mean arterial blood pressure < 50 mmHg despite adequate resuscitation and vasopressor therapy at the time of enrollment
- •Pregnancy or lactation
- •Duration of dexmedetomidine infusion < 24 hours
- •Severe valvular heart disease
- •Active seizures during this ICU admission requiring benzodiazepines
- •Proven or suspected traumatic brain injury, intracranial hemorrhage, stroke, or spinal cord injury
研究组 & 干预措施
Dexmedetomidine
Participants will receive the standard sepsis and septic shock treatment with dexmedetomidine, which is to be administered with an initial dose of 0.2 μg/kg/hour, and the infusion rate is to be titrated based on response for at least 24 hours.
干预措施: Dexmedetomidine (Drug)
Control
Participants will receive the standard sepsis and septic shock treatment and the standard sedatives without dexmedetomidine.
干预措施: Propofol (Drug)
结局指标
主要结局
Change in serum creatinine (SCr)
时间窗: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
Reduction in SCr ≥ 0.3 mg/dL within ≤ 72 hours. For patients known as acute on top of chronic kidney disease (CKD), decrease in SCr to \< 1.5 times the baseline
次要结局
- Incidence of agitation(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- Length of hospital and ICU stay(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- Incidence of Renal Replacement therapy (RRT)(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- Incidence of bradycardia(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- Incidence of hypotension(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- Change in Sequential Organ Failure Assessment (SOFA).(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- In-hospital mortality(From time of enrolment until date of death, assessed up to 1 month)
- Duration on mechanical ventilation(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
- Incidence of another organ dysfunction(Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks)
研究者
Kanzy Mostafa Hassan
Clinical Pharmacist
Cairo University