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NCT05147051
Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients
Phase 2 trial testing Meglumine Sodium Succinate in Metabolic Acidosis in 140 participants. Completed in 22 June 2022.
23 May 2022
Quick facts
| Lead sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 16 June 2021 |
| Primary completion | 23 May 2022 |
| Estimated completion | 22 June 2022 |
| Sites | 6 locations across Russia |
Drugs / interventions tested
- Meglumine Sodium Succinate — full drug profile →
- Placebo
Conditions studied
- Metabolic Acidosis — all drugs for Metabolic Acidosis →
Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company — full company profile →
Who can join
Adults 18 to 70, any sex, with Metabolic Acidosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05147051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other POLYSAN Scientific & Technological Pharmaceutical Company trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05147051 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by POLYSAN Scientific & Technological Pharmaceutical Company
- Last refreshed: 5 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05147051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing