Last reviewed · How we verify

NCT05147051

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

Completed Phase 2 Last updated 5 October 2022
What this trial tests

Phase 2 trial testing Meglumine Sodium Succinate in Metabolic Acidosis in 140 participants. Completed in 22 June 2022.

Timeline
16 June 2021
Primary endpoint
23 May 2022
22 June 2022

Quick facts

Lead sponsorPOLYSAN Scientific & Technological Pharmaceutical Company
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment140
Start date16 June 2021
Primary completion23 May 2022
Estimated completion22 June 2022
Sites6 locations across Russia

Drugs / interventions tested

Conditions studied

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company — full company profile →

Who can join

Adults 18 to 70, any sex, with Metabolic Acidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Metabolic Acidosis

Currently open trials in the same condition.

Other POLYSAN Scientific & Technological Pharmaceutical Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05147051.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing