Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT06955416
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06955416
Study Brief:
Protocol Section:
NCT06955416