Metabolic AcidosisPhase 2NCT05147051

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

A Phase 2 study testing Meglumine Sodium Succinate in people with Metabolic Acidosis, run by POLYSAN Scientific & Technological Pharmaceutical Company at 6 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Metabolic Acidosis
What is being tested?: Meglumine Sodium Succinate
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 6 sitesRussia
Study dates: 16 Jun 2021to 22 Jun 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Russia6 sites

GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich"
Arkhangelsk, 163001
Ivanovo Regional Clinical Hospital
Ivanovo, 152040
Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation
Moscow
Privolzhsky District Medical Center
Nizhny Novgorod, 603001
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
Saint Petersburg
National Research Mordovian State University n.a. N.P. Ogarev
Saransk, 430005

Other trials in Russia

About this study

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

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
Being tested: Meglumine Sodium Succinate, Placebo
Keywords: metabolic acidosis, critical illness, acid-base disorder
Medical subject headings: Acidosis, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meglumine Sodium SuccinateDrug
500 ml of 1.4% solution IV at a rate of at least 4 ml and not more than 10 ml per minute
PlaceboDrug
Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute

Study groups in NCT05147051
Study group	Role	What they receive
Reamberin group	Experimental	Patients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions). Receives: Drug: Meglumine Sodium Succinate
Placebo	Placebo comparator	Patients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 202122 Jun 2022

First posted7 Dec 2021
Study start16 Jun 2021
Primary completion23 May 2022
Study completion22 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05147051
Sponsor's protocol ID: RB-II-2020
Status last verified: Oct 2022
First submitted: 22 Oct 2021
Last updated: 5 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Acidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05147051
Acronym / sponsor ID: RB-II-2020
Conditions: Metabolic Acidosis
Keywords: metabolic acidosis, critical illness, acid-base disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
Collaborators: Atlant Clinical Ltd.
Study start: 16 Jun 2021 (actual)
Primary completion: 23 May 2022 (actual)
Study completion: 22 Jun 2022 (actual)
First posted: 7 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Reamberin group	Experimental	Drug: Meglumine Sodium SuccinatePatients receive the investigational treatment (meglumine sodium succinate), 500 ml intravenously every 8 hours (up to 6 infusions).
Placebo	Placebo comparator	Drug: PlaceboPatients receive a Placebo (Ringer's solution), 500 ml intravenously every 8 hours (up to 6 infusions).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meglumine Sodium Succinate500 ml of 1.4% solution IV at a rate of at least 4 ml and not more than 10 ml per minute	Drug	Reamberin group
PlaceboRinger's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute	Drug	Placebo

Primary outcome

Elimination of acidosis at 24 hours after the start of treatment
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
Individual participant dataSharing planned: No

Related trials for Metabolic Acidosis

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Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
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Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mikhail Yu Kirov principal investigator

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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Meglumine Sodium Succinate in people with Metabolic Acidosis, run by POLYSAN Scientific & Technological Pharmaceutical Company at 6 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elimination of acidosis at 24 hours after the start of treatment (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.