Viral Enteric Infection
Conditions
Keywords
viral enteric infection, reamberin
Brief summary
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.
Interventions
DRUGReamberin® solution for infusion, 1.5 %
Reamberin® in daily dose 10 mL/kg
Sponsors
POLYSAN Scientific & Technological Pharmaceutical Company
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Children of both sexes at the age of 1 to 6 years old inclusive; 2. 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), 3. Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.); 4. Indication for parenteral rehydratation (infusion therapy); 5. Decision of a physician on prescribing drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm POLYSAN) in the daily dose of 10 mL/kg and normal saline NaCl/5 % or 10 % solution of glucose or normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose; 6. To confirm the diagnosis by laboratory tests, biological material was taken; 7. Informed Consent Form on Participation in the Observational Program signed and dated by a parent/legal representative of the patient.
Exclusion criteria
1. 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; 2. Contraindications to prescription of drug product Reamberin®; 3. Necessity in surgical interventions during the observational program; 4. Patients previously enrolled in this trial but discontinued participation due to any any reason; 5. Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate; 6. Other conditions that, according to the Investigator, prevent enrollment of a patient into the observational trial or can result in premature discontinuation of the observational trial by the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment | 24 hours, 48 hours | 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 | Day 10 | Average duration of infusion therapy in groups, expressed in days |
| Average durations of symptoms of damage of the gastrointestinal tract in groups | Day 10 | 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 | Day 10 | Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days |
| Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment | 48 hours | Share of patients in groups with moderate form (11-15 points according to the Vesikari scale) and severe form (16 and more points according to the Vesikari scale) 48 hours after the start of the treatment (Visit 3); |
| Average duration of stay of patients in an inpatient healthcare facility | Day 10 | Average duration of stay of patients in an inpatient healthcare facility in treatment groups, expressed in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average duration of stay in the ICU | Day 10 | Average duration of stay in the ICU (intensive care unit), expressed in hours (among patients transferred into ICU) |
| Dynamics of symptoms of damage of the GI tract 24 hours and 48 hours | 24 hours, 48 hours | Dynamics of symptoms of damage of the GI (gastrointestinal) tract (nausea, vomiting, and diarrhea) 24 hours (Visit 2) and 48 hours (Visit 3) after the start of infusion therapy as compared to Visit 1; |
| Average volume of infusion therapy relative to body weight | Day 10 | Average volume of infusion therapy relative to body weight, expressed in milliliters |
| Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours and 48 hours | 24 hours, 48 hours | Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours (Visit 2) and 48 hours (Visit 3) after the start of treatment as compared to Visit 1 (among patients who underwent this analysis). |
| Dynamics of severity of dehydratation according to the CDS clinical scale 24 hours and 48 hours after the start of infusion therapy | 24 hours, 48 hours | Dynamics of severity of dehydratation according to the CDS (Clinical Dehydration Scale) clinical scale 24 hours (Visit 2) and 48 hours (Visit 3) after the start of infusion therapy as compared to Visit 1, expressed in points; |
| Dynamics of intoxication symptoms after 24 hours and 48 hours | 24 hours, 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 | 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 | 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); |
| Dynamics of fever severity after 24 hours and 48 hours | 24 hours, 48 hours | Dynamics of fever severity after 24 hours (Visit 2) and 48 hours (Visit 3) from the start of infusion therapy compared to Visit 1, expressed in degrees Celsius; |
| Average duration of fever | Day 10 | Average duration of fever, expressed in days |
Countries
Russia, Uzbekistan
Contacts
Primary ContactAlexey Kovalenko, Doc Biol Sci
Outcome results
None listed