To assess the efficacy and safety of use of drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm "POLYSAN") for pathogenetic therapy of viral enteric infection in children aged 1-6 years old in routine clinical practice. Trial population: children of both sexes at the age of 1-6 years old inclusive with viral enteric infection.
Children of both sexes at the age of 1 to 6 years old inclusive;
Diagnosis "Viral and other specified intestinal infections" (code according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision(ICD-10): A08),
Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.);
Indication for parenteral rehydratation (infusion therapy);
Individual intolerance or known hypersensitivity to sodium meglumine, sodium succinate, and/or normal saline (NaCl), solution of glucose, Ringer's solution or excipients of drug product Reamberin® based on data of medical history;
Contraindications to prescription of drug product Reamberin®;
Necessity in surgical interventions during the observational program;
Patients previously enrolled in this trial but discontinued participation due to any any reason;
Children of both sexes at the age of 1-6 years old inclusive with viral enteric infection
Case-control
Prospective
Reamberin® solution for infusion, 1.5 %
DrugReamberin® in daily dose 10 mL/kg
Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment
Share of patients in groups who continued to receive infusion therapy 24 h (Visit 2) and 48 h (Visit 3) after the start of the treatment
Average duration of infusion therapy in groups, expressed in days
Average duration of infusion therapy in groups, expressed in days
Average durations of symptoms of damage of the gastrointestinal tract in groups
Average durations of symptoms of damage of the gastrointestinal tract (nausea, vomiting, diarrhea) in groups, expressed in days;
Average duration of symptoms of intoxication in groups
Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days
Average volume of infusion therapy relative to body weight
Average volume of infusion therapy relative to body weight, expressed in milliliters
Dynamics of intoxication symptoms after 24 hours and 48 hours
Dynamics of intoxication symptoms (weakness, lethargy, hypodynamia), assessed by VAS (Visual analog scale) after 24 hours (Visit 2) and 48 hours (Visit 3) from the start of infusion therapy compared to Visit 1;
Proportion of patients with electrolyte disturbances after 24 hours
Proportion of patients with electrolyte disturbances after 24 hours (Visit 2) from the start of infusion therapy compared to Visit 1 (among patients who underwent electrolyte level testing at Visits 1 and 2);
Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours
Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours from the start of infusion therapy (among patients who underwent this testing at Visits 1 and 2);
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