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

Phase 2

Completed

• Conditions: Metabolic Acidosis
• Interventions: Drug: Placebo; Drug: Meglumine Sodium Succinate

• Registration Number: NCT05147051
• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-07
• Primary Completion: 2022-05-23
• Study Completion: 2022-06-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Signed and dated written Informed Consent (if unconscious due to a critical condition, the decision is made by a Council consisting of 3 physicians)
2. Male and female patients aged 18-70
3. 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
4. pH of arterial blood 7.20-7.35, inclusive
5. Planned volume of infusion >= 1500 ml per day
6. Interval between admission to the ICU and randomization <24 hours

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Exclusion Criteria

1. Pregnant and lactating women
2. Known hypersensitivity to any component of the study drug / placebo
3. Chronic kidney disease stage C5 (end-stage renal failure)
4. Acute hepatic failure (ALT > 15 upper normal limits) or liver cirrhosis
5. Traumatic brain injury accompanied by cerebral edema
6. Previously diagnosed mental illness
7. Any chronic disease in the terminal stage with a life expectancy of < 3 months
8. HIV infection
9. 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)
10. Extremely low or extremely high body fat
11. Infusion sodium bicarbonate, sodium bicarbonate, trometamol, Sterofundin, Quintasol, Ringer's lactate (Hartmann's solution) within 6 hours before screening
12. Acute respiratory acidosis
13. Poisoning with chemical compounds causing metabolic acidosis
14. Alcohol in saliva at screening >= 0.5 pro mille
15. Previously diagnosed chronic obstructive pulmonary disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions).
Reamberin group	Meglumine Sodium Succinate	Patients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions).

Primary Outcome Measures

Name	Time	Method
Elimination of acidosis at 24 hours after the start of treatment	24 hours	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.

Trial Locations

Locations (6)

Ivanovo Regional Clinical Hospital; 🇷🇺 Ivanovo, Russian Federation

Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation; 🇷🇺 Moscow, Russian Federation

GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"; 🇷🇺 Arkhangel'sk, Russian Federation

Privolzhsky District Medical Center; 🇷🇺 Nizhny Novgorod, Russian Federation

Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine; 🇷🇺 Saint Petersburg, Russian Federation

National Research Mordovian State University n.a. N.P. Ogarev; 🇷🇺 Saransk, Russian Federation