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 Details — Status: Completed

Administrative data

• NCT number: NCT05147051
• Other study ID #: RB-II-2020
• Status: Completed
• Phase: Phase 2
• Start date: June 16, 2021
• Est. completion date: June 22, 2022

Study information

• Verified date: October 2022
• Source: POLYSAN Scientific & Technological Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 22, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acidosis
• Metabolic Acidosis

Intervention

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

Locations

Country	Name	City	State
Russian Federation	GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"	Arkhangel'sk
Russian Federation	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	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

Sponsors (2)

Lead Sponsor	Collaborator
POLYSAN Scientific & Technological Pharmaceutical Company	Atlant Clinical Ltd.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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