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

COVID-19 Clinical Trial

— CARECOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172180
• Other study ID #: CARECOVID
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2023
• Source: POLYSAN Scientific & Technological Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Metabolic Diseases

Intervention

Drug:
• Reamberin
the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate)
• Ringer's solution
Ringer's solution at an average daily dose of 8.1 ml/kg/day

Locations

Country	Name	City	State
Russian Federation	Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko	Nizhny Novgorod

Sponsors (1)

Lead Sponsor	Collaborator
POLYSAN Scientific & Technological Pharmaceutical Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Glucose	Venous blood Glucose	baseline, day 2, day 3, day 5, day 11
Secondary	Lactate	Venous blood Lactate	baseline, day 2, day 3, day 5, day 11
Secondary	pH	Blood gases	baseline, day 2, day 3, day 5, day 11
Secondary	BE	Blood gases	baseline, day 2, day 3, day 5, day 11
Secondary	Dynamics of right diaphragm excursion, cm	Diaphragm mobility	baseline, day 2, day 3, day 5, day 11
Secondary	Total duration of inpatient treatment, days	Total duration of inpatient treatment	from date of treatment start until the date of death or the date of discharge from hospital

External 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