Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
研究概览
简要总结
The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.
详细描述
Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Covid-19 positive
- •Admission to Critical Care Unit
- •Bladder catheter in situ
- •Central line in place (including PICC line)
- •Written informed consent to participate in the study
排除标准
- •Stage 3 AKI (as defined by KDIGO criteria)
- •Chronic kidney disease stage 4 or 5
- •Contraindications to NaHCO3 therapy (e.g. risk of serious drug interaction, systemic metabolic alkalosis, congestive heart failure)
- •Urine pH > 7.0
- •Serum sodium >150mmol/L
- •Blood pressure >180/100mgHg
- •Severe hypokalaemia (K<3.0mmol/L)
- •Inability to grant informed consent
- •Severe hypocalcaemia (Cai <0.8 mmol/L)
- •Pregnant or lactating and breast-feeding women
- •Unwilling to use contraception
- •Patient is on a medication that may interact with sodium bicarbonate
研究组 & 干预措施
Sodium bicarbonate
Intravenous sodium bicarbonate infusion
干预措施: Sodium Bicarbonate 150Meq/L/D5W Inj (Drug)
结局指标
主要结局
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
时间窗: up to 10 days after intensive care unit admission
proportion of patients treated who achieve \>50% of urine measurements above pH 7.0 over the duration of intervention
次要结局
- number of days alive and free of stage 2-3 AKI (up to day 28) in each group(up to day 28 after randomisation)
- ventilator-free days(up to day 28 after randomisation)
- hospital-free days(up to day 60 after randomisation)
- proportion of patients developing stage 2-3 AKI(up to day 28 after randomisation)