Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients

  • STATUS
    Recruiting
  • days left to enroll
    72
  • participants needed
    140
  • sponsor
    POLYSAN Scientific & Technological Pharmaceutical Company
Updated on 12 December 2021

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.

Details
Condition Metabolic Acidosis
Treatment Placebo, Meglumine Sodium Succinate
Clinical Study IdentifierNCT05147051
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
Last Modified on12 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed and dated written Informed Consent (if unconscious due to a critical condition, the decision is made by a Council consisting of 3 physicians)
Male and female patients aged 18-70
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
pH of arterial blood 7.20-7.35, inclusive
Planned volume of infusion >= 1500 ml per day
Interval between admission to the ICU and randomization <24 hours

Exclusion Criteria

Pregnant and lactating women
Known hypersensitivity to any component of the study drug / placebo
Chronic kidney disease stage C5 (end-stage renal failure)
Acute hepatic failure (ALT > 15 upper normal limits) or liver cirrhosis
Traumatic brain injury accompanied by cerebral edema
Previously diagnosed mental illness
Any chronic disease in the terminal stage with a life expectancy of < 3 months
HIV infection
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)
Extremely low or extremely high body fat
Infusion sodium bicarbonate, sodium bicarbonate, trometamol, Sterofundin, Quintasol, Ringer's lactate (Hartmann's solution) within 6 hours before screening
Acute respiratory acidosis
Poisoning with chemical compounds causing metabolic acidosis
Alcohol in saliva at screening >= 0.5 pro mille
Previously diagnosed chronic obstructive pulmonary disease
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