A Prospective Open Label Randomized Non Inferiority Trial to Compare the Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.
研究概览
简要总结
The Patient evaluated in Emergency room since admission and detailed history and clinical examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive Care Unit (ICU) in view of septic shock were included since onset of shock.
Initial fluid resuscitation done and if the patient were no fluid responsive they were randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the primary objectives. At the same time the strict vitals monitoring and standard medical therapy for sepsis including antibiotics and other supportive therapy continued. The patients were followed up till discharge, death or up to 28days after enrollment into the protocol (whichever the longest). The detail methodology has been explained in column 14 later.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of cirrhosis or ACLF (Acute on Chronic Liver Failure) with septic shock (defined later).
- •Age 18-70yrs
- •An informed consent from the patient or relative
排除标准
- •Pronounced cardiac dysfunction( valvular heart disease, coronary artery disease),
- •Acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. Reynaud's syndrome or related diseases).
- •Pregnancy
- •Previous history of transplantation on immunosuppressant.
- •Acute gastrointestinal bleed.(defined later)
研究组 & 干预措施
Noradrenaline
Noradrenaline: Noradrenaline 2amp (4000mcg in 50ml) at 6ml/hr = 7.5mcg/min and dose maximum 60mcg/min 24ml/hr double strength. The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure)>65.
干预措施: Noradrenaline (Drug)
Terlipressin
Terlipressin (1.3mcg/min i.e 2mg over 24 hr to max of terlipressin 5.2mcg/min i.e. up to 8mg over 24hr) .The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure)>65 .Terlipressin 2mg in 48ml,1ml=42mcg=0.67mg/min, max dose 8mg/day- 8ml/hr of infusion.
干预措施: Terlipressin (Drug)
结局指标
主要结局
The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.
时间窗: 48 hrs
次要结局
- Mortality(Day 3, Day 7 and Day 28)
- Length of stay(Within 28 days)
- Days free of vasopressors(Within 28 days)
- Days free of steroid(Within 28 dyas)
- Incidence of serious adverse events.(Within 28 days.)
- Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)(Within 28 days)
- Days free of ventilatory support(Within 28 days)