Effect of Neostigmine on outcomes in patients with Septic Shock: A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- SOFA score
研究概览
简要总结
Though fluid resuscitation remains the first line therapy for management of hypotension including the one associated with sepsis. Overjealous use of fluids can lead to venous congestion, raised central venous pressure which can impair the microcirculatory blood flow thus reducing tissue perfusion. The surviving sepsis 2021 guidelines have also downgraded the recommendation of giving 30 ml/kg of crystalloids, from ‘Strong’ to ‘Weak’ with low quality of evidence. Recent data has shown that early initiation of vasopressors in patients with sepsis is associated with decreased mortality. Noradrenaline is the vasopressor of choice in patients with septic shock. It is more potent than dopamine and has a lower incidence of arrythmias. However, a high dose of noradrenaline is associated with decreased lactate clearance and makes lactate an unreliable marker for tissue perfusion.
Vagus nerve was identified to play an anti-inflammatory role in patients with gram negative endotoxemia. The cholinergic anti-inflammatory pathway (CAP) attenuates systemic inflammatory response with nicotinic acetylcholine receptor as a main target. This inflammatory modulation might have therapeutic applications in patients with infection or inflammatory conditions of lungs. In humans, pyridostigmine has been used for treatment of septic shock caused by intra-abdominal infection. The study found that the use of physostigmine will cause a reduction in the noradrenaline requirement however the SOFA score were not significantly different between the two groups (physostigmine vs placebo). A recent study using neostigmine found it to significantly improve SOFA scores in patients with sepsis. However it also involved only 45 postsurgical patients and could not find a statistically significant difference in SOFA scores among patients with septic shock.
So, currently the role of neostigmine in improving outcomes in patients with septic shock is still debatable. Therefore we plan this randomised controlled trial to study the effect of neostigmine infusion on outcomes in adult patients with septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients who are admitted to the ICU with septic shock of less than 24-hour duration.
排除标准
- •Patients who refuse to consent for the study.
- •Patients with SOFA score of 6 or more.
- •Patients with asthma, bradycardia or heart block, head injury, muscle dystrophy, urinary or gastrointestinal obstruction.
- •Pregnant patients or lactating mothers Patients with known allergy to neostigmine.
结局指标
主要结局
SOFA score
时间窗: Day five post ICU admission
次要结局
- Relative change in SOFA score (deltaSOFA) from baseline(Day five post ICU admission)
- Ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2)(Day 0(baseline), 3, 5 and 7 post ICU admission)
- GCS score(Day 0(baseline), 3, 5 and 7 post ICU admission)
- Reversal of shock(Day 3, 5 and 7 post ICU admission)
- Need for mechanical ventilation(Day 0(baseline), 3, 5 and 7 post ICU admission)
- Successful extubation(Day 3, 5 and 7 post ICU admission)
- Mortality(28 days post ICU admission)
- Length of ICU stay(28 days post ICU admission)
- Length of hospital stay(28 days post ICU admission)
- Complications(Day five post ICU admission)
研究者
Dr Deepak Singla
AIIMS Rishikesh