Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19

Study Overview
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Brief Summary
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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

Official Title
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Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Reamberin
* Drug: Ringer's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The control group<br>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 | Drug: Ringer's solution<br>* Ringer's solution at an average daily dose of 8.1 ml/kg/day<br>|
| The test group<br>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 | Drug: Reamberin<br>* the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, % | Proportion of patients died during the period of hospital stay | from date of treatment start until the date of death or the date of discharge from hospital | 
| Duration of treatment at ICU, days | Duration of treatment at ICU | from date of treatment start until the date of death or the date of discharge from hospital | 
| Duration of treatment after ICU, days | Duration of treatment after ICU | from date of treatment start until the date of death or the date of discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Venous blood Glucose | baseline, day 2, day 3, day 5, day 11 | 
| Lactate | Venous blood Lactate | baseline, day 2, day 3, day 5, day 11 | 
| pH | Blood gases | baseline, day 2, day 3, day 5, day 11 | 
| BE | Blood gases | baseline, day 2, day 3, day 5, day 11 | 
| Dynamics of right diaphragm excursion, cm | Diaphragm mobility | baseline, day 2, day 3, day 5, day 11 | 
| Total duration of inpatient treatment, days | Total duration of inpatient treatment | from date of treatment start until the date of death or the date of discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, METABOLIC DISORDERS, Respiratory function of the lungs