Status:
RECRUITING
REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Diabetic Ketoacidosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
A number of scientific papers have been published on the efficacy and safety of adding REAMBERIN® (meglumin sodium succinate), a 1.5% infusion solution, to standard therapy for patients with diabetic ...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Male and female patients aged 18-75 years, inclusive.
- Confirmed diagnosis of type 1 or type 2 diabetes mellitus
- Established clinical diagnosis of DKA at the time of admission
- Plasma glucose \> 13.9 mmol / l
- Metabolic acidosis (venous blood pH \< 7.25)
- Serum bicarbonate \< 18 mmol / l
- Ketonuria ≥ ++
- Possibility of randomizing the patient within 2 hours from admission to the hospital.
Exclusion
- Known hypersensitivity to any component of the study drug/standard therapy p
- Blood pH ≤ 6.9 or standard bicarbonate level \<5 mmol/l
- Previous use of other solutions containing reserve alkalinity carriers (acetate, lactate, malate, fumarate, etc).
- Conditions requiring emergency surgical intervention
- Abdominal surgeries in the last 14 days
- Traumatic brain injury accompanied by cerebral edema.
- Chronic treatment with steroids, atypical antipsychotics, cancer chemotherapy.
- Acute kidney injury
- Chronic kidney disease stage C5
- Liver injury (increase in alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels by more than 5 times the established reference values).
- Acute pancreatitis
- Sepsis
- Severe multiple or combined trauma
- History of malignancy
- Clinically significant cardiovascular diseases (acute coronary syndrome; acute cerebrovascular accident (CVA) or transient ischemic attack (TIA); chronic heart failure class III - IV according to the NYHA classification; severe uncontrolled arrhythmia).
- Body mass index \>=40.0
- Alcohol abuse, drug use, drug use.
- Other specific types of diabetes mellitus.
- Previously diagnosed mental illness
- Participation in another clinical trial or the use of drugs/dietary supplements containing succinic acid less than 30 days before inclusion in this study.
- Pregnancy or breastfeeding.
- SARS-CoV-2 infection
- Low systolic blood pressure (BP) (≤70 mmHg) upon admission to hospital or at the time of inclusion in the study.
- Contraindications to the infusion of REAMBERIN of 0.9% sodium chloride solution.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06955416
Start Date
May 1 2025
End Date
December 31 2027
Last Update
June 24 2025
Active Locations (3)
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1
State Budgetary Institution of Healthcare of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Russia
2
Regional budgetary healthcare institution "Ivanovo regional clinical hospital"
Ivanovo, Russia
3
Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky
Kemerovo, Russia