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

NCT05147051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-10-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Atlant Clinical Ltd.

    collaborator OTHER

  • POLYSAN Scientific & Technological Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Mikhail Yu Kirov · GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2022-05-23
Completion
2022-06-22

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05147051 on ClinicalTrials.gov