Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension: A Randomized Controlled Trial (ALPS Plus)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving Mean Arterial Pressure above 65mm of Hg at 3 hrs after intervention
研究概览
简要总结
Cirrhotic patients with sepsis represent a very sick subset of patients and septic shock in such patients is associated with high mortality. Early initiation of intravenous fluids and antibiotics is the key to management in these patients. The choice of fluid in cirrhotic patients with sepsis induced hypotension has been studied in the past. The choice of fluid, crystalloid vs colloid, for resuscitation in such patients has been a matter of debate. In the previous study, the ALPS trial, 20% albumin use was associated with a better reversal of hypotension but was associated with an increased incidence of pulmonary complications and 5% albumin was better when compared to normal saline(FRISC study) for fluid resuscitation. No study in the past has evaluated 5% albumin against 20% albumin in combination with crystalloid. Investigator aim to study the efficacy and safety of 20% albumin with plasmalyte against 5 % albumin for fluid resuscitation in cirrhotic patients with sepsis induced hypotension.
详细描述
Hypothesis: Combination of 20% albumin with plasmalyte could be better than 5% albumin for fluid resuscitation in critically ill cirrhosis patients due to less incidence of hyperchloremic metabolic acidosis, dyselectrolytemia, fluid overload, and due to its cost effectiveness.
Aim: To compare the efficacy and safety of 20% albumin plus plasmalyte against 5% albumin for reversal of sepsis induced hypotension at 3 hrs in cirrhosis patients
Primary objective: To compare the efficacy of 20% albumin combined with plasmalyte against 5% albumin for reversal of shock at 3 hours after initiation of fluids in cirrhosis patients with sepsis induced hypotension
Secondary objectives:
- To study the effects of 5% albumin against 20% albumin plus plasmalyte on reversal of shock at 6, 12, 24hrs.
- to study the effects of 5% albumin against 20% albumin plus plasmalyte on arterial lactates
- To study the effect on AKI, chloride levels and coagulation in the two arms
- To study the time to initiation of noradrenaline in the two arms and the cumulative dose of norepinephrine administered in the two arms
- To study the effects of fluid resuscitation on urine output and heart rate in the two arms
- To study the effects of 5% albumin against 20% albumin plus plasmalyte on cardiopulmonary status using point of care ultrasound(POCUS)
- To study the effect of 5% albumin compared to 20% albumin plus plasmalyte on 28-day mortality.
- To study the effect of 5% albumin compared to 20% albumin plus plasmalyte on requirement and initiation of RRT
- To study the adverse effects of albumin infusion and 20% albumin plus plasmalyte infusion when used as resuscitation fluids
- To study the effect of fluid resuscitation on S. albumin concentration and effective albumin concentration in the two arms
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - 18-75 yrs of age
- •Cirrhotic patients with sepsis induced hypotension defined as mean arterial pressure less than 65mm of Hg with suspected (as per history and examination) or documented evidence of infection.
排除标准
- •Patients with other causes of hypotension
- •Patients who have already received bolus of 5% albumin or plasmalyte or >2L of fluids
- •Patients with structural heart disease or known diastolic dysfunction or cirrhotic cardiomyopathy
- •Patients who are on vasopressors or inotropes,
- •Patients already receiving renal replacement therapy
- •Patients with known chronic obstructive lung disease or congestive heart failure
- •Patients with serum albumin below 1.5 g/dl
- •Patients in need of surgical intervention
- •Pregnant or lactating women
- •Patients with a previous adverse reaction to human albumin.
研究组 & 干预措施
20% albumin infusion with plasmalyte
- Plamalyte will be given at an initial bolus of 15-20 ml/kg over 15-30 mins followed by 100ml/hr maintenance
- S. albumin > 3 g/dl: 20g of 20% iv albumin @10-15 ml/hr
- S. albumin < 3 g/dl: 40g of 20% iv albumin @10-15 ml/hr
干预措施: 20% Albumin (Biological)
20% albumin infusion with plasmalyte
- Plamalyte will be given at an initial bolus of 15-20 ml/kg over 15-30 mins followed by 100ml/hr maintenance
- S. albumin > 3 g/dl: 20g of 20% iv albumin @10-15 ml/hr
- S. albumin < 3 g/dl: 40g of 20% iv albumin @10-15 ml/hr
干预措施: Plasmalyte (Drug)
5% albumin at an initial bolus of 5ml/kg iv over 15-30 mins followed by 50ml/hr maintenance dose
5% albumin at an initial bolus of 5ml/kg iv over 15-30 mins followed by 50ml/hr maintenance dose
- In case of failure to attain a sustained MAP >65 mmHg, Fluid boluses will be administered guided by lung ultrasound and IVC
- Group A: Plasmalyte bolus of 15-20 ml/kg over 15-30 mins
- Group B: 5ml/kg of 5% albumin over 15-30 mins
干预措施: 5% Albumin (Biological)
结局指标
主要结局
Proportion of patients achieving Mean Arterial Pressure above 65mm of Hg at 3 hrs after intervention
时间窗: 3 hours
次要结局
- Time to initiation of norepinephrine in the two arms(24 hour)
- To study the adverse effects (including pulmonary, metabolic and coagulopathy) in the two groups.(Day 28)
- Cumulative dose of norepinephrine in two arms(24 hour)
- Cumulative amount of fluid used in two arms.(24 hour)
- Mortality in the two groups(28 days)
- Proportion of patients with reversal of shock in the two groups.(24 hours)
- Effect of fluid resuscitation on lactate clearance in the two groups.(24 hour)
- Length of ICU stay in the two groups(28 days)