Ethanol IntoxicationNCT05715723
Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication
An observational study of Ethanol Intoxication, run by POLYSAN Scientific & Technological Pharmaceutical Company at 18 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Ethanol Intoxication
- What is being tested?
- Reamberin
- How many people
- 296 participants
- Where
- 18 sitesRussia
- Study dates
- 15 Sep 2022to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
City Clinical Hospital of Emergency Medical Care
Kaliningrad
K.N. Shevchenko Kaluga Regional Clinical Hospital of Emergency Medical Care
Kaluga
M.A. Podgorbunsky Kuzbass Clinical Hospital of Emergency Medical Care
Kuzbass
Buyanov City Clinical Hospital
Moscow
KORSAKOV Medical Center
Moscow
N.V. Sklifosovsky Research Institute of Emergency Care of the Moscow City Health Department
Moscow
Negovsky Research Institute of General Intensive Care Medicine
Moscow
Zhukovskaya City Clinical Hospital
Moscow
City Clinical Hospital No. 2
Novosibirsk
City Clinical Hospital of Emergency Medicine No. 1
Omsk
Regional Clinical Hospital,
Ryazan
City Mariinskaya Hospital
Saint Petersburg
City Narcological Hospital
Saint Petersburg
Dzhanelidze St. Petersburg Research Institute of Emergency Medicine
Saint Petersburg
State Healthcare Institution Saratov Yu. Ya. Gordeev City Clinical Hospital No. 1
Saratov
V.N. Koshelev City Clinical Hospital No. 6
Saratov
Tyumen State Medical University
Tyumen
Yaroslavl Regional Clinical Narcological Hospital
Yaroslavl
About this study
Official title: Non-interventional, Prospective Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication: Hospital Practice
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.
Read the 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.
- Conditions
- Ethanol Intoxication
- Being tested
- Reamberin
- Keywords
- reamberin, intensive care, acute ethanol intoxication, Ethanol Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReamberinDrug
Reamberin® in the average daily dose of 10 ml/kg daily
| Study group | Role | What they receive |
|---|---|---|
| The control group | Standard therapy | |
| The test group | Standard therapy + Reamberin Receives: Drug: Reamberin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the average stay duration at ICU between patient groups.
Measured: Up to 2 weeks
Difference in the average consciousness recovery duration between patient groups.
Measured: 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
Measured: 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
Measured: 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.
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.
Measured: 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.
Measured: 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.
Sepsis-related Organ Failure scale: min 0 points, max 24 points. The higher the total score, the higher the degree of multiple organ failure
Measured: Baseline, 24 hours after the intervention, up to 2 weeks
Dynamics of consciousness level score according to Glasgow Coma Scale during the study, measured in both groups.
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.
Measured: Baseline, 24 hours after the intervention, up to 2 weeks
Dynamics of the total score according to ICDSC scale (Intensive Care Delirium Screening Checklist) during the study, measured in both groups
Intensive Care Delirium Screening Checklist: ыcore ≥ 4 - delirium
Measured: Baseline, 24 hours after the intervention, up to 2 weeks
Percentage of patients, who developed delirium, measured in both groups
Measured: Up to 2 weeks
Percentage of patients, who developed hospital-acquired pneumonia, measured in both groups
Measured: Up to 2 weeks
Percentage of patients, who developed extrapulmonary complications, measured in both groups.
Measured: Up to 2 weeks
Percentage of lethal outcomes for the whole study period, measured in both groups.
Measured: Up to 2 weeks
Percentage of patients, for whom it became necessary to administer ALV, over the whole study period, measured in both groups.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Sep 2022
- Primary completion1 Nov 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethanol IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715723
- Sponsor's protocol ID
- Reamberin\2022\01
- Status last verified
- Nov 2024
- First submitted
- 28 Dec 2022
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Prospective Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication: Hospital Practice
- ClinicalTrials.gov ID
- NCT05715723
- Acronym / sponsor ID
- Reamberin\2022\01
- Conditions
- Ethanol Intoxication
- Keywords
- reamberin, intensive care, acute ethanol intoxication, Ethanol Intoxication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | –Standard therapy |
| The test group | – | Drug: ReamberinStandard therapy + Reamberin |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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:
- Primary diagnosis:
- Blood ethanol concentration: 1.5 ‰ (per mille) and more.
- Consciousness depression (Glasgow Coma Score = 6-12)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReamberinReamberin® in the average daily dose of 10 ml/kg daily | Drug | The test group |
Primary outcome
Difference in the average stay duration at ICU between patient groups.
Time frame: Up to 2 weeks
Difference in the average consciousness recovery duration between patient groups.
Time frame: Up to 2 weeks
12 secondary outcomes
Difference in average blood lactate levels between the groups, measured at the baseline and after 24 hours of the therapy
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 24 hours after the intervention, up to 2 weeks
Dynamics of consciousness level score according to Glasgow Coma Scale during the study, measured in both groups.
Time frame: Baseline, 24 hours after the intervention, up to 2 weeks
Dynamics of the total score according to ICDSC scale (Intensive Care Delirium Screening Checklist) during the study, measured in both groups
Time frame: Baseline, 24 hours after the intervention, up to 2 weeks
Percentage of patients, who developed delirium, measured in both groups
Time frame: Up to 2 weeks
Percentage of patients, who developed hospital-acquired pneumonia, measured in both groups
Time frame: Up to 2 weeks
Percentage of patients, who developed extrapulmonary complications, measured in both groups.
Time frame: Up to 2 weeks
Percentage of lethal outcomes for the whole study period, measured in both groups.
Time frame: Up to 2 weeks
Percentage of patients, for whom it became necessary to administer ALV, over the whole study period, measured in both groups.
Time frame: Up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ethanol Intoxication, run by POLYSAN Scientific & Technological Pharmaceutical Company at 18 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the average stay duration at ICU between patient groups. (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.