Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication

Polysan

Status

Completed

Conditions

Ethanol Intoxication

Treatments

Drug: Reamberin

Study type

Observational

Funder types

Industry

Identifiers

NCT05715723

Reamberin\2022\01

Details and patient eligibility

About

Acute ethanol intoxication is the most frequent pathologic condition developing in subjects using alcohol. The severity of disorders in acute alcohol intoxication is determined, first of all, by the quantity of consumed alcohol and the duration of the toxic effect. When toxic doses of alcohol are taken per os, a life-threatening condition develops, which is manifested by consciousness depression and severe metabolism disorders. Reamberin (1.5 % meglumine sodium succinate solution) is an infusion solution with a balanced electrolyte composition and succinic acid, which is recommended for rehydration and detoxication in patients with intoxications of different genesis. The metabolic effect of Reamberin helps restore homeostasis and improve the natural organism detoxication. The investigators suppose that administration of Reamberin to patients with acute ethanol intoxication will make it possible to improve the treatment quality as compared to the standard therapy.

Full description

All drugs will be administered according to the instruction for medical use and conventional clinical practice.

The decision on the selection of therapy shall be made by a medical investigator irrespective of the protocol before the inclusion of a patient in the study.

Enrollment

296 patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients aged from 22 to 65 years.
It is planned to administer one of the following treatment types to the patient, as part of the routine clinical practice:
- Standard fluid administration + Reamberin®. It is planned to administer the drug Reamberin® in the average daily dose of 10 ml/kg daily for the whole period of treatment at ICU.
- Standard fluid administration (without the use of the drug Reamberin®).
Primary diagnosis:
- toxic effect of ethanol (T51.0 according to ICD-10);
- acute intoxication caused by the simultaneous use of several narcotic drugs and the use of other psychoactive substances2 (F19.0 according to ICD-10);
- mental and behavioral disorders caused by alcohol use. Acute intoxication (F10.0 according to ICD-10).
Blood ethanol concentration: 1.5 ‰ (per mille) and more.
Consciousness depression (Glasgow Coma Score = 6-12)
Laboratory signs of a shift in the acid-base balance towards metabolic acidosis: base deficit (BE) of venous blood less than -2.2 mmol/l).
Availability of the written consent of the patient or his (her) legally authorized representative.

Exclusion criteria

Use of other drugs containing malate or succinate.
Consciousness depression with Glasgow Coma Score of lower than 6.
Intoxication with addictive substances and psychotropic drugs.
Shock.
Body weight of less than 50 kg or more than 120 kg.
Data on the presence of malignant neoplasms.
Decompensation of chronic pulmonary diseases with the development of respiratory failure of degree II-III as at the time of inclusion in the study.
Pregnancy, breast feeding.
Craniocerebral injury or polytrauma.
Acute cerebrovascular accident.
Infection-inflammatory disease of CNS (meningitis, encephalitis etc.) and other variants of CNS function disorder not associated with ethanol intoxication.
Respiratory impairment requiring ALV.
Contraindications mentioned in the approved instructions for the use of the drugs used in the study.
A disease or the use of drugs, which, in the physician's opinion, can influence safety, tolerance and efficiency of the study drugs.