Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of REAMBERIN® (Meglumine Sodium Succinate) Used for Correction of Metabolic Acidosis in Critically Ill Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Elimination of acidosis at 24 hours after the start of treatment
研究概览
简要总结
An acid-base imbalance, called metabolic acidosis (acid-base disorder lasting from several minutes to several days, caused by a decrease in serum bicarbonate ion (HCO3) concentration), is often observed in critically ill patients with various underlying diseases. Metabolic acidosis has a negative impact on the cardiovascular, respiratory, digestive, nervous, excretory, hematological, endocrine, musculoskeletal and immune systems and is associated with unfavourable outcomes. Reamberin® is a solution of disubstituted sodium salt of succinic acid, which has an alkaline reaction and succinate is capable to integrate into the Krebs cycle and restore energy metabolism in the cell. The aim of the present study is to evaluate the efficacy and safety of meglumine sodium succinate at a dose of 500 to 3000 ml in critically ill patients with metabolic acidosis and choose the optimal volume of its solution for the correction of metabolic acidosis in critically ill patients.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Signed and dated written Informed Consent (if unconscious due to a critical condition, the decision is made by a Council consisting of 3 physicians)
- •Male and female patients aged 18-70
- •Critical illness ((shock (including traumatic, hypovolemic), major trauma, acute massive blood loss, acute complicated surgical diseases of the abdominal organs) accompanied by metabolic acidosis, defined as serum bicarbonate <22mmol/L
- •pH of arterial blood 7.20-7.35, inclusive
- •Planned volume of infusion >= 1500 ml per day
- •Interval between admission to the ICU and randomization <24 hours
排除标准
- •Pregnant and lactating women
- •Known hypersensitivity to any component of the study drug / placebo
- •Chronic kidney disease stage C5 (end-stage renal failure)
- •Acute hepatic failure (ALT > 15 upper normal limits) or liver cirrhosis
- •Traumatic brain injury accompanied by cerebral edema
- •Previously diagnosed mental illness
- •Any chronic disease in the terminal stage with a life expectancy of < 3 months
- •HIV infection
- •Clinically significant cardiovascular disease (unstable angina pectoris or angina pectoris of functional class III or higher; chronic heart failure III - IV class according to NYHA; acute myocardial infarction within 6 months before screening)
- •Extremely low or extremely high body fat
- •Infusion sodium bicarbonate, sodium bicarbonate, trometamol, Sterofundin, Quintasol, Ringer's lactate (Hartmann's solution) within 6 hours before screening
- •Acute respiratory acidosis
- •Poisoning with chemical compounds causing metabolic acidosis
- •Alcohol in saliva at screening >= 0.5 pro mille
- •Previously diagnosed chronic obstructive pulmonary disease
研究组 & 干预措施
Reamberin group
Patients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions).
干预措施: Meglumine Sodium Succinate (Drug)
Placebo
Patients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions).
干预措施: Placebo (Drug)
结局指标
主要结局
Elimination of acidosis at 24 hours after the start of treatment
时间窗: 24 hours
The proportion of patients who have achieved normalization of the serum bicarbonate level (normalization = serum hydrocarbonate ion concentration ≥22 mmol / Liter), at 24 hours after the start of therapy.
次要结局
未报告次要终点