The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- the required duration to achieve the target MAP
研究概览
简要总结
Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of > 2 mmol/L (18 mg/dL) despite sufficient volume resuscitation
. Hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock
详细描述
Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of > 2 mmol/L (18 mg/dL) despite sufficient volume resuscitation . Hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock
. When mean arterial pressure (MAP) falls below a specific critical level organ blood flow is physiologically dependent on perfusion pressure. Fluid resuscitation and vasopressors have an influence on hypovolemia and the vascular tone in the early phase, as fluid resuscitation aims to correct hypovolemia and vasopressors-norepinephrine (NE)- as a first-line drug aiming to restore vascular tone to assure organ perfusion
. Norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone and contractility
. Nevertheless, a large amount of fluids will increase the risk of fluid overload, which is a common complication during septic shock resuscitation
- After the early phase, only fifty percent of patients respond to fluid administration, meaning that fluid treatment cannot boost cardiac output (CO) The current data indicate that the time from the onset of septic shock to the initiation of norepinephrine administration is a significant survival predictor; however, a suggestion for the optimal time to provide norepinephrine support was not explicitly expressed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Adult patients aged from18 to 65 years old
- •had the diagnostic criteria for sepsis as the presence of infection
- •systemic manifestations of infection and signs of Hypoperfusion
排除标准
- •Acute cerebral vascular event
- •Active cardiac conditions
- •Valvular heart diseases
- •Hypotension suspected to be due to another cause and comorbidities
- •Status asthmatics
- •Active hemorrhage
- •Pregnancy
- •Burn injury
- •Requirement for immediate surgery
- •Advanced-stage cancer
- •Refusal to participate in the study
研究组 & 干预措施
A
patients received (30ml /kg) ringer's lactate solution after first presentation then norepinephrine was added when persistent mean arterial pressure (MAP)> 65 mmHg despite adequate fluid resuscitation
干预措施: Crystalloid (Drug)
B
patients received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)
干预措施: noradrenaline (Drug)
结局指标
主要结局
the required duration to achieve the target MAP
时间窗: 24 hours since the diagnosis of sepsis
time to achieve target mean arterial pressure over or equal to 65 mmHg once the diagnosis of sepsis is confirmed, is the target to stop fluid management.
次要结局
未报告次要终点
研究者
tarek abdel hay mostafa
principle investigator
Tanta University