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

NCT05172180 | Completed

• 1 other identifier: CARECOVID
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

COVID-19; METABOLIC DISORDERS; Respiratory function of the lungs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Glucose

  baseline, day 2, day 3, day 5, day 11

• Lactate

  baseline, day 2, day 3, day 5, day 11

• pH

  baseline, day 2, day 3, day 5, day 11

• BE

  baseline, day 2, day 3, day 5, day 11

• Dynamics of right diaphragm excursion, cm

  baseline, day 2, day 3, day 5, day 11

Study Arms (2)

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

Drug: Ringer's solution

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

Drug: Reamberin

Interventions

Reamberin DRUG

the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate)

The test group

Ringer's solution DRUG

Ringer's solution at an average daily dose of 8.1 ml/kg/day

The control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe novel coronavirus infection COVID-19 (NCI) who were treated at the intensive care unit (ICU)

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (1)

Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko

Nizhny Novgorod, Russia

Location

Related Links

• Metabolic therapy and its impact on lung respiratory function in patients with severe COVID-19 A.Yu. Yakovlev, A.A. Pevnev, M.V. Dudorova, Yu.V. Ilyin, M.S. Belous https://doi.org/10.17816/KMJ2022-364

MeSH Terms

Conditions

COVID-19; Metabolic Diseases

Interventions

Reamberin; Ringer's Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 29, 2021
• Study Start: December 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: April 1, 2021
• Last Updated: December 19, 2024

Record last verified: 2023-12

Locations

RU (1)