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

Active, not recruiting

• Conditions: Ethanol Intoxication
• Interventions: Drug: Reamberin

• Registration Number: NCT05715723
• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 286

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, 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®).

3. Primary diagnosis: toxic effect of ethanol.

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

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

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

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

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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 respiratory failure 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 other variants 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 drugs used in the study.
14. A disease or the use of drugs, which, in the physician's opinion, can influence safety, tolerance and efficiency of the study drugs.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The test group	Reamberin	Standard therapy + Reamberin

Primary Outcome Measures

Name	Time	Method
Difference in the average consciousness recovery duration between patient groups.	Up to 2 weeks
Difference in the average stay duration at ICU between patient groups.	Up to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Difference in average blood lactate levels between the groups, measured at the baseline and after 24 hours of the therapy	Baseline, 24 hours after the intervention
Difference in average serum bicarbonate levels between the groups, measured at the baseline and after 24 hours of the therapy	Baseline, 24 hours after the intervention
Percentage of patients, for whom it became necessary to administer ALV, over the whole study period, measured in both groups.	Up to 2 weeks
Percentage of patients, whose consciousness recovered to Glasgow Coma Score of up to 14 after 24 hours of the therapy, measured in both groups.	24 hours after the intervention	The Glasgow Coma Scale: 15 points - clear consciousness.; 14-13 points - moderate stunning.; 12-11 points - deep stunning.; 10-8 points - sopor.; 7-6 points - moderate coma.; 5-4 points - deep coma.; 3 points - terminal coma, brain death.
Dynamics of serum bicarbonate levels during the study (at the baseline, in 24 hours, by the end of the treatment in ICU), measured in both groups.	Baseline, 24 hours after the intervention, up to 2 weeks
Dynamics of organ failure score according to SOFA scale during the study, measured in both groups.	Baseline, 24 hours after the intervention, up to 2 weeks	Sepsis-related Organ Failure scale: min 0 points, max 24 points. The higher the total score, the higher the degree of multiple organ failure
Dynamics of consciousness level score according to Glasgow Coma Scale during the study, measured in both groups.	Baseline, 24 hours after the intervention, up to 2 weeks	The Glasgow Coma Scale: 15 points - clear consciousness.; 14-13 points - moderate stunning.; 12-11 points - deep stunning.; 10-8 points - sopor.; 7-6 points - moderate coma.; 5-4 points - deep coma.; 3 points - terminal coma, brain death.
Dynamics of the total score according to ICDSC scale (Intensive Care Delirium Screening Checklist) during the study, measured in both groups	Baseline, 24 hours after the intervention, up to 2 weeks	Intensive Care Delirium Screening Checklist: ыcore ≥ 4 - delirium
Percentage of patients, who developed delirium, measured in both groups	Up to 2 weeks
Percentage of patients, who developed hospital-acquired pneumonia, measured in both groups	Up to 2 weeks
Percentage of patients, who developed extrapulmonary complications, measured in both groups.	Up to 2 weeks
Percentage of lethal outcomes for the whole study period, measured in both groups.	Up to 2 weeks

Trial Locations

Locations (9)

Buyanov City Clinical Hospital; 🇷🇺 Moscow, Russian Federation

KORSAKOV Medical Center; 🇷🇺 Moscow, Russian Federation

Negovsky Research Institute of General Intensive Care Medicine; 🇷🇺 Moscow, Russian Federation

City Clinical Hospital No. 2; 🇷🇺 Novosibirsk, Russian Federation

City Clinical Hospital of Emergency Medicine No. 1; 🇷🇺 Omsk, Russian Federation

Regional Clinical Hospital,; 🇷🇺 Ryazan', Russian Federation

Dzhanelidze St. Petersburg Research Institute of Emergency Medicine; 🇷🇺 Saint Petersburg, Russian Federation

City Mariinskaya Hospital; 🇷🇺 St. Petersburg, Russian Federation

Yaroslavl Regional Clinical Narcological Hospital; 🇷🇺 Yaroslavl, Russian Federation