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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05172180
Acronym
CARECOVID
Enrollment
105
Registered
2021-12-29
Start date
2020-12-01
Completion date
2021-04-01
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

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

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

Interventions

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

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

Sponsors

POLYSAN Scientific & Technological Pharmaceutical Company
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality, %from date of treatment start until the date of death or the date of discharge from hospitalProportion of patients died during the period of hospital stay
Duration of treatment at ICU, daysfrom date of treatment start until the date of death or the date of discharge from hospitalDuration of treatment at ICU
Duration of treatment after ICU, daysfrom date of treatment start until the date of death or the date of discharge from hospitalDuration of treatment after ICU

Secondary

MeasureTime frameDescription
BEbaseline, day 2, day 3, day 5, day 11Blood gases
Glucosebaseline, day 2, day 3, day 5, day 11Venous blood Glucose
Total duration of inpatient treatment, daysfrom date of treatment start until the date of death or the date of discharge from hospitalTotal duration of inpatient treatment
Dynamics of right diaphragm excursion, cmbaseline, day 2, day 3, day 5, day 11Diaphragm mobility
Lactatebaseline, day 2, day 3, day 5, day 11Venous blood Lactate
pHbaseline, day 2, day 3, day 5, day 11Blood gases

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026