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

Completed

• Conditions: COVID-19
• Interventions: Drug: Reamberin; Drug: Ringer's solution

• Registration Number: NCT05172180
• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-04-01
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2021-12-29
• Status Verified: 2023-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. age 18-70 years;
2. diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
3. the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
4. initiation of infusion therapy on the 1st day after patient admission to ICU

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The test group	Reamberin	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
The control group	Ringer's solution	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

Primary Outcome Measures

Name	Time	Method
Duration of treatment after ICU, days	from date of treatment start until the date of death or the date of discharge from hospital	Duration of treatment after ICU
Mortality, %	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	from date of treatment start until the date of death or the date of discharge from hospital	Duration of treatment at ICU

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko; 🇷🇺 Nizhny Novgorod, Russian Federation