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Completed

NCT Number: NCT05172180

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko

Nizhny Novgorod, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reamberin

Drug

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

Ringer's Solution

Drug

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

Primary outcomes

  1. Mortality, %

    Time frame: 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

  2. Duration of treatment at ICU, days

    Time frame: from date of treatment start until the date of death or the date of discharge from hospital

    Duration of treatment at ICU

  3. Duration of treatment after ICU, days

    Time frame: from date of treatment start until the date of death or the date of discharge from hospital

    Duration of treatment after ICU

Secondary outcomes

  1. Glucose

    Time frame: baseline, day 2, day 3, day 5, day 11

    Venous blood Glucose

  2. Lactate

    Time frame: baseline, day 2, day 3, day 5, day 11

    Venous blood Lactate

  3. pH

    Time frame: baseline, day 2, day 3, day 5, day 11

    Blood gases

  4. BE

    Time frame: baseline, day 2, day 3, day 5, day 11

    Blood gases

  5. Dynamics of right diaphragm excursion, cm

    Time frame: baseline, day 2, day 3, day 5, day 11

    Diaphragm mobility

  6. Total duration of inpatient treatment, days

    Time frame: from date of treatment start until the date of death or the date of discharge from hospital

    Total duration of inpatient treatment

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Acronym: CARECOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2021
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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