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

Inclusion Criteria:

1. Male and female patients aged from 22 to 65 years.

2. It is planned to administer one of the following treatment types to the patient, aspart of the routine clinical practice:

• Standard fluid administration + Reamberin®. It is planned to administer thedrug Reamberin® in the average daily dose of 10 ml/kg daily for the wholeperiod of treatment at ICU.

• Standard fluid administration (without the use of the drug Reamberin®).

3. Primary diagnosis:

• toxic effect of ethanol (T51.0 according to ICD-10);

• acute intoxication caused by the simultaneous use of several narcotic drugs andthe 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).

4. Blood ethanol concentration: 1.5 ‰ (per mille) and more.

5. Consciousness depression (Glasgow Coma Score = 6-12)

6. 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).

7. Availability of the written consent of the patient or his (her) legally authorizedrepresentative.

Exclusion Criteria:

1. Use of other drugs containing malate or succinate.

2. Consciousness depression with Glasgow Coma Score of lower than 6.

3. Intoxication with addictive substances and psychotropic drugs.

4. Shock.

5. Body weight of less than 50 kg or more than 120 kg.

6. Data on the presence of malignant neoplasms.

7. Decompensation of chronic pulmonary diseases with the development of respiratoryfailure of degree II-III as at the time of inclusion in the study.

8. Pregnancy, breast feeding.

9. Craniocerebral injury or polytrauma.

10. Acute cerebrovascular accident.

11. Infection-inflammatory disease of CNS (meningitis, encephalitis etc.) and othervariants of CNS function disorder not associated with ethanol intoxication.

12. Respiratory impairment requiring ALV.

13. Contraindications mentioned in the approved instructions for the use of the drugsused in the study.

14. A disease or the use of drugs, which, in the physician's opinion, can influencesafety, tolerance and efficiency of the study drugs.