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| Name | Class |
|---|---|
| Atlant Clinical Ltd. | OTHER |
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An acid-base imbalance, called metabolic acidosis (acid-base disorder lasting from several minutes to several days, caused by a decrease in serum bicarbonate ion (HCO3) concentration), is often observed in critically ill patients with various underlying diseases. Metabolic acidosis has a negative impact on the cardiovascular, respiratory, digestive, nervous, excretory, hematological, endocrine, musculoskeletal and immune systems and is associated with unfavourable outcomes. Reamberin® is a solution of disubstituted sodium salt of succinic acid, which has an alkaline reaction and succinate is capable to integrate into the Krebs cycle and restore energy metabolism in the cell. The aim of the present study is to evaluate the efficacy and safety of meglumine sodium succinate at a dose of 500 to 3000 ml in critically ill patients with metabolic acidosis and choose the optimal volume of its solution for the correction of metabolic acidosis in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reamberin group | Experimental | Patients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions). |
|
| Placebo | Placebo Comparator | Patients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meglumine Sodium Succinate | Drug | 500 ml of 1.4% solution IV at a rate of at least 4 ml and not more than 10 ml per minute |
|
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of acidosis at 24 hours after the start of treatment | The proportion of patients who have achieved normalization of the serum bicarbonate level (normalization = serum hydrocarbonate ion concentration ≥22 mmol / Liter), at 24 hours after the start of therapy. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Yu Kirov | GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich" | Arkhangelsk | 163001 | Russia | |||
| Ivanovo Regional Clinical Hospital |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C549374 | Reamberin |
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| Placebo | Drug | Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute |
|
| Ivanovo |
| 152040 |
| Russia |
| Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation | Moscow | Russia |
| Privolzhsky District Medical Center | Nizhny Novgorod | 603001 | Russia |
| Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine | Saint Petersburg | Russia |
| National Research Mordovian State University n.a. N.P. Ogarev | Saransk | 430005 | Russia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |