An observational study in Ethanol Intoxication, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Completed at 18 sites in Russian Federation. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Observational
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.
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.
209 studies on the registry are indexed under Poisoning; 26 are open to participants now.
This study's enrollment of 296 is above the median of 121 across 94 observational studies indexed under Poisoning.
Browse Poisoning studies →POLYSAN Scientific & Technological Pharmaceutical Company is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
It is planned to administer one of the following treatment types to the patient, as part of the routine clinical practice:
Primary diagnosis:
Exclusion Criteria:
Standard therapy
Standard therapy + Reamberin
Drug: Reamberin
Reamberin® in the average daily dose of 10 ml/kg daily
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
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.
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.
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.
Sepsis-related Organ Failure scale: min 0 points, max 24 points. The higher the total score, the higher the degree of multiple organ failure
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.
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.
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
Intensive Care Delirium Screening Checklist: ыcore ≥ 4 - delirium
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
POLYSAN Scientific & Technological Pharmaceutical Company