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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group | Standard therapy | ||
| The test group | Standard therapy + Reamberin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reamberin | Drug | Reamberin® in the average daily dose of 10 ml/kg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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)
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.
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital of Emergency Medical Care | Kaliningrad | Russia | ||||
| K.N. Shevchenko Kaluga Regional Clinical Hospital of Emergency Medical Care |
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| 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. | 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. | Sepsis-related Organ Failure scale: min 0 points, max 24 points. The higher the total score, the higher the degree of multiple organ failure | 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. | 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 | Baseline, 24 hours after the intervention, up to 2 weeks |
| 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 |
| Percentage of patients, for whom it became necessary to administer ALV, over the whole study period, measured in both groups. | Up to 2 weeks |
| Kaluga |
| Russia |
| M.A. Podgorbunsky Kuzbass Clinical Hospital of Emergency Medical Care | Kuzbass | Russia |
| Buyanov City Clinical Hospital | Moscow | Russia |
| KORSAKOV Medical Center | Moscow | Russia |
| N.V. Sklifosovsky Research Institute of Emergency Care of the Moscow City Health Department | Moscow | Russia |
| Negovsky Research Institute of General Intensive Care Medicine | Moscow | Russia |
| Zhukovskaya City Clinical Hospital | Moscow | Russia |
| City Clinical Hospital No. 2 | Novosibirsk | Russia |
| City Clinical Hospital of Emergency Medicine No. 1 | Omsk | Russia |
| Regional Clinical Hospital, | Ryazan | Russia |
| City Mariinskaya Hospital | Saint Petersburg | Russia |
| City Narcological Hospital | Saint Petersburg | Russia |
| Dzhanelidze St. Petersburg Research Institute of Emergency Medicine | Saint Petersburg | Russia |
| State Healthcare Institution Saratov Yu. Ya. Gordeev City Clinical Hospital No. 1 | Saratov | Russia |
| V.N. Koshelev City Clinical Hospital No. 6 | Saratov | Russia |
| Tyumen State Medical University | Tyumen | Russia |
| Yaroslavl Regional Clinical Narcological Hospital | Yaroslavl | Russia |
| ID | Term |
|---|---|
| C549374 | Reamberin |
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