Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- time to achievemnets of theraputeic endpoints of hemodynamics
研究概览
简要总结
The aim of the study is to detect wither dobutamine or milrinone have a privilege in the management of low cardiac output pediatric patients over the other.
详细描述
Randomized controlled trials (RCTs) enrolling critically ill patients with low cardiac output syndrome (LCOS) admitted at pediatrics emergency and intensive care units ,Cairo University Children's Hospital, identified by treating medical team as requiring initiation of inotropic therapy based on healthcare team assessment of :
- Capillary refill time > 3 sec
- Hypotension (less than the 5th percentile or less than 90/50 mmHg for children 10 years or older (Kleinman et al.,2010) (Haque et al .,2007)
- Oliguria (urine output that is less than 1 mL/kg/h in infants, less than 0.5 mL/kg/h in children ) (Nakano et al.,2022)
- Metabolic acidosis with base excess > -2 (Nakano et al.,2020)
Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need.
Every patient will be evaluated after the first 24 hours of starting the inotropic therapy by :
- pre and post inotropic therapy ICON measurements ( evaluating cardiac index and systemic vascular resistance pre and post inotropic support)
- pre and post inotropic therapy echocardiography ( evaluating systolic and diastolic dysfunction by M-mode and two dimensional methods) through measuring LV EDD cm, LV ESD cm, LV EDV ml, LVESV ml, FS% , LV mass, EF% , MAPSE cm, TAPSE cm.
- pre and post inotropic therapy clinical assessment of vital signs (heart rate , blood pressure, capillary refill time and urine output as mention before)
- The need of titration up of inotropes :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
. Cardiac assessment will be done by a blinded pediatric cardiologist.
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-Patients from age of 1 month to 14 years old of both sexes.
- •2-Patients presenting with fluid refractory shock with low cardiac output state, evidenced by sustained hypotension (systolic blood pressure below 5th percentile for age) and end organ dysfunction (altered level of consciousness, renal or hepatic dysfunction)
- •3-Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics
- •4-Refractory heart failure requiring admission for inotropic support.
排除标准
- •1-All other causes of pediatric shock not in need for inotropic support (eg.isolated hypovolemic shock, anaphylaxis,....)
- •2 - patients not fit for randomization needing specific line of management (eg. Sever hypotension patients with good filling pressure unfit for milrinone , patients previously known having sever pulmonary hypertension not fit for dobutamine ,...)
- •3-post cardiac surgery patients with low cardiac output manifestation.
研究组 & 干预措施
patients who will recieve dobutrex
patient presenting with acute heart failure , who will recieve dobutrex as a result of their randomixation , startng dose will be 5 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state
干预措施: Dobutamine (Drug)
patients who will recieve milirinone
patient presenting with acute heart failure , who will recieve milirinone as a result of their randomixation , startng dose will be 0.25 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state
干预措施: Dobutamine (Drug)
结局指标
主要结局
time to achievemnets of theraputeic endpoints of hemodynamics
时间窗: first 24 hrs
( normal blood pressure and clinically adequate cardiac output)
次要结局
- Correlation between the used inotropic support and the survival to discharge .(first week)
- Total time on inotropes and average length of stay at a pediatric intensive care unit.(first week)
- Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population.(first 24 hrs)
- Need for up-titration or addition of other inotropic support.(first 24 hrs)
研究者
Nada Gamal
pediatric resident
Cairo University