Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Duration of treatment after ICU, days
研究概览
简要总结
Objective of the study: to investigate the effect of meglumine succinate solution on the dynamics of metabolic blood parameters and respiratory function of the lungs in intensive care patients with new coronavirus infection. An observational prospective study included 105 patients with a severe course of novel coronavirus infection
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age 18-70 years;
- •diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
- •the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
- •initiation of infusion therapy on the 1st day after patient admission to ICU
排除标准
- •presence of initial indications for transfer to invasive ALV at the time of screening; 2) history of Reamberin intolerance; 3) administration of other polyelectrolyte solutions with reserve alkalinity carriers; 4) pregnancy and postpartum; 5) severe renal failure requiring renal replacement therapy; 6) severe hepatic failure (Child-Pugh class C or higher); 7) diabetes mellitus; 8) terminal stage of other chronic incurable diseases
研究组 & 干预措施
The control group
The control group consisted of 54 patients who received Ringer's solution at an average daily dose of 8.1 ml/kg/day as the main infusion solution from the time of transfer to the intensive care unit
干预措施: Ringer's solution (Drug)
The test group
Fifty one patients in the test group received the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate) at an average daily dose of 8.3 ml/kg/day for the same purpose
干预措施: Reamberin (Drug)
结局指标
主要结局
Duration of treatment after ICU, days
时间窗: from date of treatment start until the date of death or the date of discharge from hospital
Duration of treatment after ICU
Mortality, %
时间窗: from date of treatment start until the date of death or the date of discharge from hospital
Proportion of patients died during the period of hospital stay
Duration of treatment at ICU, days
时间窗: from date of treatment start until the date of death or the date of discharge from hospital
Duration of treatment at ICU
次要结局
- BE(baseline, day 2, day 3, day 5, day 11)
- pH(baseline, day 2, day 3, day 5, day 11)
- Dynamics of right diaphragm excursion, cm(baseline, day 2, day 3, day 5, day 11)
- Lactate(baseline, day 2, day 3, day 5, day 11)
- Glucose(baseline, day 2, day 3, day 5, day 11)
- Total duration of inpatient treatment, days(from date of treatment start until the date of death or the date of discharge from hospital)