Metabolic Acidosis
Conditions
Keywords
metabolic acidosis, critical illness, acid-base disorder
Brief summary
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.
Interventions
DRUGMeglumine Sodium Succinate
500 ml of 1.4% solution IV at a rate of at least 4 ml and not more than 10 ml per minute
DRUGPlacebo
Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute
Sponsors
Atlant Clinical Ltd.
POLYSAN Scientific & Technological Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated written Informed Consent (if unconscious due to a critical condition, the decision is made by a Council consisting of 3 physicians) 2. Male and female patients aged 18-70 3. Critical illness ((shock (including traumatic, hypovolemic), major trauma, acute massive blood loss, acute complicated surgical diseases of the abdominal organs) accompanied by metabolic acidosis, defined as serum bicarbonate \<22mmol/L 4. pH of arterial blood 7.20-7.35, inclusive 5. Planned volume of infusion \>= 1500 ml per day 6. Interval between admission to the ICU and randomization \<24 hours
Exclusion criteria
1. Pregnant and lactating women 2. Known hypersensitivity to any component of the study drug / placebo 3. Chronic kidney disease stage C5 (end-stage renal failure) 4. Acute hepatic failure (ALT \> 15 upper normal limits) or liver cirrhosis 5. Traumatic brain injury accompanied by cerebral edema 6. Previously diagnosed mental illness 7. Any chronic disease in the terminal stage with a life expectancy of \< 3 months 8. HIV infection 9. Clinically significant cardiovascular disease (unstable angina pectoris or angina pectoris of functional class III or higher; chronic heart failure III - IV class according to NYHA; acute myocardial infarction within 6 months before screening) 10. Extremely low or extremely high body fat 11. Infusion sodium bicarbonate, sodium bicarbonate, trometamol, Sterofundin, Quintasol, Ringer's lactate (Hartmann's solution) within 6 hours before screening 12. Acute respiratory acidosis 13. Poisoning with chemical compounds causing metabolic acidosis 14. Alcohol in saliva at screening \>= 0.5 pro mille 15. Previously diagnosed chronic obstructive pulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elimination of acidosis at 24 hours after the start of treatment | 24 hours | 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. |
Countries
Russia
Outcome results
None listed