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

NCT05715723 | Completed

• 1 other identifier: Reamberin\2022\01
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 18

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.

Conditions

Ethanol Intoxication

Keywords

reamberin; intensive care; acute ethanol intoxication; Ethanol Intoxication

Outcome Measures

Primary Outcomes (2)

• Difference in the average stay duration at ICU between patient groups.

  Up to 2 weeks

• Difference in the average consciousness recovery duration between patient groups.

  Up to 2 weeks

Secondary Outcomes (12)

• 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, 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

• 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

Study Arms (2)

The control group

Standard therapy

The test group

Standard therapy + Reamberin

Drug: Reamberin

Interventions

Reamberin DRUG

Reamberin® in the average daily dose of 10 ml/kg daily

The test group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ethanol intoxication, hospitalized to an intensive care unit with signs of toxic encephalopathy (consciousness depression level: Glasgow Coma Score = 6-12) and metabolic acidosis

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (18)

City Clinical Hospital of Emergency Medical Care

Kaliningrad, Russia

Location

K.N. Shevchenko Kaluga Regional Clinical Hospital of Emergency Medical Care

Kaluga, Russia

Location

M.A. Podgorbunsky Kuzbass Clinical Hospital of Emergency Medical Care

Kuzbass, Russia

Location

Buyanov City Clinical Hospital

Moscow, Russia

Location

KORSAKOV Medical Center

Moscow, Russia

Location

N.V. Sklifosovsky Research Institute of Emergency Care of the Moscow City Health Department

Moscow, Russia

Location

Negovsky Research Institute of General Intensive Care Medicine

Moscow, Russia

Location

Zhukovskaya City Clinical Hospital

Moscow, Russia

Location

City Clinical Hospital No. 2

Novosibirsk, Russia

Location

City Clinical Hospital of Emergency Medicine No. 1

Omsk, Russia

Location

Regional Clinical Hospital,

Ryazan, Russia

Location

City Mariinskaya Hospital

Saint Petersburg, Russia

Location

City Narcological Hospital

Saint Petersburg, Russia

Location

Dzhanelidze St. Petersburg Research Institute of Emergency Medicine

Saint Petersburg, Russia

Location

State Healthcare Institution Saratov Yu. Ya. Gordeev City Clinical Hospital No. 1

Saratov, Russia

Location

V.N. Koshelev City Clinical Hospital No. 6

Saratov, Russia

Location

Tyumen State Medical University

Tyumen, Russia

Location

Yaroslavl Regional Clinical Narcological Hospital

Yaroslavl, Russia

Location

MeSH Terms

Interventions

Reamberin

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: February 8, 2023
• Study Start: September 15, 2022
• Primary Completion: November 1, 2024
• Study Completion: February 28, 2025
• Last Updated: April 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (18)