Trials / Completed
CompletedNCT05715723
Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication
Non-interventional, Prospective Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication: Hospital Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 296 (actual)
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Reamberin | Reamberin® in the average daily dose of 10 ml/kg daily |
Timeline
- Start date
- 2022-09-15
- Primary completion
- 2024-11-01
- Completion
- 2025-02-28
- First posted
- 2023-02-08
- Last updated
- 2025-04-18
Locations
18 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05715723. Inclusion in this directory is not an endorsement.