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

December 7, 2023 updated by: POLYSAN Scientific & Technological Pharmaceutical Company
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Nizhny Novgorod, Russian Federation
        • Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Ringer's solution at an average daily dose of 8.1 ml/kg/day
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
the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARECOVID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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