Therapeutic response of early institution of noradrenaline in patients with sepsis with hypotension presenting to emergency department
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To study shock control rate in terms of achievement of sustained MAP greater than 65 mm Hg, urine output of greater than 0.5 ml/kg/h for 2 consecutive hours, or decrease in serum lactate by more than 10% from the initial lactate level in patients of sepsis with hypotension by 6 hours of presentation to emergency department.
研究概览
简要总结
Recent retrospective evidence suggests the efficacy of early noradrenaline administration during resuscitation; however, prospective data to support this assertion are scarce.The information from this study will make it easier to comprehend how prompt vasopressor support is not only essential for survival but may also be linked to reversing organ failure and shortening hospital stays. Many studies have compared different vasopressor agents for the resuscitation of septic shock but very few have investigated the role that the timing of vasopressor initiation in relation to hypotension onset plays in outcome.Data in relation to the populations of India and Asia are still scarce.In order to make this research relevant to the Indian populace, we intend to conduct it at our institution.The aim of this study is to assess the difference in outcomes in patients with sepsis (SIRS > 2) receiving noradrenaline within 3 hrs and 3 to 6 hrs of emergency medicine department presentation. We hope to learn how the timing of noradrenaline delivery in patients of sepsis with hypotension affects mortality, recovery, hospital stay, need for ventilation and haemodialysis, through this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients above 18 years of age 2.All patients with hypotension determined by mean arterial pressure lower than 65 mm Hg and infection as the suspected cause if they met diagnostic criteria for sepsis according to surviving sepsis guidelines more than or equal to 2 of SIRS criteria.
排除标准
- •All those patients who already received vasopressors from outside
- •Patients in whom other causes of shock are found eventually in the course of study
- •Patients requiring vasopressors other than noradrenaline
- •Pregnant females.
结局指标
主要结局
To study shock control rate in terms of achievement of sustained MAP greater than 65 mm Hg, urine output of greater than 0.5 ml/kg/h for 2 consecutive hours, or decrease in serum lactate by more than 10% from the initial lactate level in patients of sepsis with hypotension by 6 hours of presentation to emergency department.
时间窗: 6 hours of presentation to emergency department.
次要结局
- To estimate duration of hospital stay, duration of ICU stay, and in-hospital mortality in patients of sepsis with hypotension receiving noradrenaline within 3 hrs and 3 to 6 hrs of emergency medicine department presentation.
- To estimate number of patients requiring mechanical ventilator support and number of patients requiring renal replacement therapy among patients of sepsis with hypotension receiving noradrenaline within 3 hrs and 3 to 6 hrs of emergency medicine department presentation.(28 days)
研究者
Aparna Ramjan
AIIMS PATNA