Comparative analysis of vasopressor weaning strategies in Septic shock evaluating the clinical outcomes of Noradrenaline first vs vasopressin first approaches A randomised control trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
Septic shock is a severe and life threatening form of sepsis marked by major disturbances in circulation cellular function and metabolism leading to high mortality. It is commonly defined by persistent low blood pressure requiring vasopressor support to maintain adequate mean arterial pressure along with elevated serum lactate levels despite proper fluid resuscitation. Even with improvements in intensive care practices septic shock continues to carry high rates of illness and death worldwide.
A key aspect of septic shock management is the use of vasopressors to support blood pressure and organ perfusion. Noradrenaline and vasopressin are commonly used agents. Noradrenaline is widely accepted as the first line vasopressor because it effectively increases vascular tone with a relatively lower risk of heart rhythm disturbances. Vasopressin works through a different mechanism and is usually added when blood pressure remains low despite adequate doses of noradrenaline. While initiation of vasopressors is well studied the best method for reducing and stopping these drugs once the patient stabilizes remains unclear.
In routine practice the order of vasopressor withdrawal often depends on clinician preference rather than strong evidence. Some studies suggest that the sequence of discontinuation may affect blood pressure stability need for restarting vasopressors length of intensive care stay and overall outcomes. Stopping a vasopressor too early may cause instability while prolonged use may increase the risk of side effects related to each drug.
Noradrenaline has a short duration of action and can be adjusted easily whereas vasopressin has a longer lasting effect and is usually given at a fixed dose. These differences suggest that the order of weaning may influence patient recovery. However high quality randomized trials comparing these strategies are limited.
This study aims to compare noradrenaline first versus vasopressin first weaning strategies in patients with septic shock receiving both agents. By evaluating outcomes such as blood pressure stability need for restarting vasopressors intensive care stay and mortality this trial seeks to provide evidence to guide clinical decision making and improve care for patients with septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (more than or equal to 18 years) admitted to the ICU with a diagnosis of septic shock based on Sepsis-3 criteria.
- •Treated with both norepinephrine and vasopressin for at least 12 hours.
- •Achieved hemodynamic stability (MAP more than or equal to 65 mmHg) with stable or decreasing vasopressor requirements.
- •All patients on invasive hemodynamic monitoring.
排除标准
- •Patients or legally authorized representative refusing consent Use of additional vasopressors for example epinephrine dopamine Hemodynamic instability requiring escalation at the time of weaning Severe cardiac arrhythmias including ventricular fibrillation ventricular tachycardia paroxysmal supraventricular tachycardia second degree heart block third degree heart block complete heart block atrial fibrillation causing instability Cardiogenic shock Advanced liver failure Left ventricular ejection fraction less than 45 percent on bedside echocardiography Pregnant or lactating women Any patient or their legally authorized representative who withdraws consent at any time during the conduct of the study will not be included in the study.
研究者
Akash Ray Mohapatra
Armed forces medical college