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

Primary Purpose

Metabolic Acidosis

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Meglumine Sodium Succinate
Placebo
Sponsored by
POLYSAN Scientific & Technological Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis focused on measuring metabolic acidosis, critical illness, acid-base disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"
  • Ivanovo Regional Clinical Hospital
  • Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation
  • Privolzhsky District Medical Center
  • Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
  • National Research Mordovian State University n.a. N.P. Ogarev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reamberin group

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2021
Last Updated
October 4, 2022
Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company
Collaborators
Atlant Clinical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05147051
Brief Title
Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company
Collaborators
Atlant Clinical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis
Keywords
metabolic acidosis, critical illness, acid-base disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reamberin group
Arm Type
Experimental
Arm Description
Patients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions).
Intervention Type
Drug
Intervention Name(s)
Meglumine Sodium Succinate
Intervention Description
500 ml of 1.4% solution IV at a rate of at least 4 ml and not more than 10 ml per minute
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute
Primary Outcome Measure Information:
Title
Elimination of acidosis at 24 hours after the start of treatment
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Yu Kirov
Organizational Affiliation
GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"
Official's Role
Principal Investigator
Facility Information:
Facility Name
GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"
City
Arkhangel'sk
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
Ivanovo Regional Clinical Hospital
City
Ivanovo
ZIP/Postal Code
152040
Country
Russian Federation
Facility Name
Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation
City
Moscow
Country
Russian Federation
Facility Name
Privolzhsky District Medical Center
City
Nizhny Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Facility Name
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
City
Saint Petersburg
Country
Russian Federation
Facility Name
National Research Mordovian State University n.a. N.P. Ogarev
City
Saransk
ZIP/Postal Code
430005
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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

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