2025-523914-10-00招募中4 期
Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with metabolic acidosis and acute kidney injury
Universitaet Muenster23 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2026年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 660
- 试验地点
- 23
- 主要终点
- Major adverse kidney events (MAKE90) Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90
研究概览
简要总结
To investigate the effect of sodium bicarbonate on major adverse kidney events at day 90
研究设计
- 分配方式
- Randomized
- 主要目的
- Sodium bicarbonate in ESCALATE allocation and interim analysis
- 盲法
- Double (Investigator, Analyst, Carer, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years
- •Critically ill patients (requiring treatment on an Intensive Care Unit or Intermediate Care Unit)
- •Metabolic acidosis, defined as all of the following: a. Arterial pH ≤7.25 b. PaCO2 < 6.5kPa (<49 mmHg) c. Standard bicarbonate ≤20 mmol/L d. Standard Base Excess <-2
- •AKI stage 2 or 3 of the KDIGO classification
- •Written informed consent of the patient or legal representative or authorized representative or emergency inclusion (according to Article 35 EU-Regulation 536/2014)
排除标准
- •Respiratory acidosis (acute or chronic)
- •Symptomatic hypocalcaemia (Ionized calcium <1.05 mmol/L)
- •Hypernatremia (plasma sodium >150 mmol/L)
- •Severe hypokalemia (potassium <3.0 mmol/L)
- •Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer
- •Deemed unsuitable for KRT
- •High output stoma/ileostomy
- •Percutaneous biliary drainage
- •End stage kidney failure defined as documented eGFR <15ml/min/1.73m2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysi
- •Known renal tubular acidosis
- •Diabetic ketoacidosis
- •High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
研究组 & 干预措施
SODIUM HYDROGEN CARBONATE
Test
干预措施: SODIUM HYDROGEN CARBONATE (Drug)
结局指标
主要结局
Major adverse kidney events (MAKE90) Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90
Major adverse kidney events (MAKE90) Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90
次要结局
- 90-day all-cause mortality (%)
- Elevation of the creatinine level to ≥200% of baseline value at day 90 (one measurement between day 80 and 120 after randomization)
- Receipt of any form of KRT within the 90-day time period after randomization
- Kidney Replacement Therapy (KRT)-dependence at day 90 after randomization
- KRT-free days, defined as difference between number of days alive and number of days receiving KRT of any form between randomization and day 90
研究者
Principal Coordinating Investigator
Scientific
Universitaet Muenster
研究点 (23)
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