NCT05147051

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Acidosis

Interventions

Type	Name	Description
DRUG	Meglumine 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
DRUG	Placebo	Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute

Timeline

• Start date: 2021-06-16
• Primary completion: 2022-05-23
• Completion: 2022-06-22
• First posted: 2021-12-07
• Last updated: 2022-10-05

Locations

6 sites across 1 country: Russia