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

Last updated: December 11, 2024
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Reamberin

Clinical Study ID

NCT05715723
Reamberin\2022\01
  • Ages 22-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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®).

  1. Primary diagnosis: toxic effect of ethanol.

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

  3. Consciousness depression (Glasgow Coma Score = 7-12)

  4. Metabolic acidosis: Base excess of venous blood: from -12 to -3 mmol/l.

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

Exclusion

Exclusion Criteria:

  1. Use of other drugs containing malate or succinate.

  2. Consciousness depression with Glasgow Coma Score of lower than 7.

  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.

Study Design

Total Participants: 286
Treatment Group(s): 1
Primary Treatment: Reamberin
Phase:
Study Start date:
September 15, 2022
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Buyanov City Clinical Hospital

    Moscow,
    Russian Federation

    Site Not Available

  • KORSAKOV Medical Center

    Moscow,
    Russian Federation

    Site Not Available

  • Negovsky Research Institute of General Intensive Care Medicine

    Moscow,
    Russian Federation

    Site Not Available

  • City Clinical Hospital No. 2

    Novosibirsk,
    Russian Federation

    Site Not Available

  • City Clinical Hospital of Emergency Medicine No. 1

    Omsk,
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital,

    Ryazan',
    Russian Federation

    Site Not Available

  • Dzhanelidze St. Petersburg Research Institute of Emergency Medicine

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • City Mariinskaya Hospital

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Yaroslavl Regional Clinical Narcological Hospital

    Yaroslavl,
    Russian Federation

    Site Not Available

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