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

Metabolic Acidosis Clinical Trial

Official 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05147051
Study type Interventional
Source POLYSAN Scientific & Technological Pharmaceutical Company
Contact
Status Completed
Phase Phase 2
Start date June 16, 2021
Completion date June 22, 2022
View Details
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