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

NCT05147051 | Completed Phase 2

• 1 other identifier: RB-II-2020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

metabolic acidosis; critical illness; acid-base disorder

Outcome Measures

Primary Outcomes (1)

• Elimination of acidosis at 24 hours after the start of treatment

  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.

  24 hours

Study Arms (2)

Reamberin group

EXPERIMENTAL

Patients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions).

Drug: Meglumine Sodium Succinate

Placebo

PLACEBO COMPARATOR

Patients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions).

Drug: Placebo

Interventions

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

Reamberin group

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead
• Atlant Clinical Ltd.: collaborator

Study Sites (6)

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

Arkhangelsk, 163001, Russia

Location

Ivanovo Regional Clinical Hospital

Ivanovo, 152040, Russia

Location

Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation

Moscow, Russia

Location

Privolzhsky District Medical Center

Nizhny Novgorod, 603001, Russia

Location

Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine

Saint Petersburg, Russia

Location

National Research Mordovian State University n.a. N.P. Ogarev

Saransk, 430005, Russia

Location

MeSH Terms

Conditions

Acidosis; Critical Illness

Interventions

Reamberin

Condition Hierarchy (Ancestors)

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

Study Officials

• Mikhail Yu Kirov

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: December 7, 2021
• Study Start: June 16, 2021
• Primary Completion: May 23, 2022
• Study Completion: June 22, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)