Using REAMBERIN® for treating diabetic ketoacidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of REAMBERIN® 1.5% infusion solution in conjunction with standard therapy for patients diagnosed with diabetic ketoacidosis (DKA). It is a multicenter, randomized, double-blind study that will assess two different doses of the medication compared to a placebo. The trial aims to determine if the addition of REAMBERIN® can lead to a quicker resolution of DKA, reduced ICU stay, and faster hospital discharge. The study is designed in two stages, with the first stage focusing on dose evaluation and the second stage on broader patient recruitment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• State Budgetary Institution of Healthcare of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
  Arkhangelsk, Russia Recruiting
• Regional budgetary healthcare institution "Ivanovo regional clinical hospital"
  Ivanovo, Russia Recruiting
• Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky
  Kemerovo, Russia Recruiting

Study contacts

• Study coordinator: Alexey Kovalenko, Doc Biol Sci
• Email: science@polysan.ru
• Phone: +78127108225

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Perfusion index in the emergency department to gauge DKA severity

  This study tests whether the perfusion index measured at ED admission can help predict how severe diabetic ketoacidosis will be in adults.

  Recruiting Ankara Etlik City Hospital · Ankara, Ankara and 1 other locations · NCT07820371

• Markers of early kidney and heart injury in children newly diagnosed with type 1 diabetes

  This study will test whether blood markers and heart ultrasound can find early kidney or heart injury in children aged 2–16 who are newly diagnosed with type 1 diabetes, comparing those with diabetic ketoacidosis, those without, and healthy children.

  Recruiting Aristotle University Of Thessaloniki · Thessaloniki, Central Makedonia · NCT07483879

• Recognizing dapagliflozin overdose in ICU patients admitted for metformin poisoning.

  This project will see if clinical signs and routine lab tests can help doctors tell whether adults in the ICU for metformin poisoning also took too much dapagliflozin.

  Recruiting Centre Hospitalier de Saint-Denis · Saint-Denis, France · NCT07193069

• Intravenous arginine to help treat diabetic ketoacidosis in people with type 2 diabetes

  This study tests whether a single IV dose of arginine given early in DKA can safely boost your own insulin and help adults with ketone-prone type 2 diabetes recover faster.

  Recruiting Phase 1/2 Wayne State University · Detroit, Michigan · NCT07167693

• Evaluating serum ferritin levels in patients with diabetic ketoacidosis

  This study is testing if measuring ferritin levels in adults with diabetic ketoacidosis can help predict how severe their condition is and what their short-term outcomes might be.

  Recruiting Sohag University · Sohag, Sohag Governorate · NCT06748365

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.