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

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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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Critical Illness Disease Attributes Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich", Arkhangelsk, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute

Primary outcomes

Elimination of acidosis at 24 hours after the start of treatment

Time frame: 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.

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Collaborators

Atlant Clinical Ltd.

Registry information

Official study title

Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of REAMBERIN® (Meglumine Sodium Succinate) Used for Correction of Metabolic Acidosis in Critically Ill Patients

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Dec 7, 2021
Registry last updated: Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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