Septic shock
Conditions
Interventions
Group 1 (Experimental): Conventional treatment +Biomodulina T. The conventional treatment(treatment established in the “José Luis Miranda” Pediatic Intensive Care Unit (PICU) based on international co
= 1 year 1 bb = 3 mg, on alternate days the first 14 days, and twice a week the following 14 days, for a total of 11 doses, parenteral route. During admission to the PICU, intravenous route (IV) will
Immunologic Factors Injections
Injections, Intramuscular
Infusions, Parenteral
Administration, Intravenous
Sponsors
Centro Nacional de Biopreparados (BioCen)
Eligibility
Sex/Gender
All
Age
29 Days to 8 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Patients aged = 29 days and <9 years. 3. Patients whose parents or legal guardians give their consent to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1. Patients in whom randomization is not possible within the first 24 hours of being diagnosed. 2. Patients with histories of severe allergic reactions and / or generalized severe eczema. 3. Patients with a diagnosis of tumor or autoimmune disease. 4. Patients with a previous diagnosis of primary immunodeficiency. 5. Patients with a solid organ or stem cell transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 28-day mortality (Depending on the condition of the patient, alive or deceased). Measurement time: final evaluation (2 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Organic dysfunction (Number of organs affected (1, 2, 3, more than 3)). Measurement time: in the initial evaluation (day 1). 2. New dysfunction or progression of the previous one (Occurrence (yes or no), Degree of dysfunction (From 0 to 33 points)). Measurement time: in daily evaluations during admission to the PICU. 3. Degree of dysfunction (It will measure through the PELOD questionnaire). Measurement time: in the evaluations during admission to the PICU (Days 1, 2, 5, 8, 12, 16 and 18). If the patient leaves the PICU before any of those days, it is not evaluated. 4. New acquired infection (Occurrence (yes or no), classification (nosocomial or community)). Measurement time: daily evaluations during admission to the PICU, evaluations during treatment with BMT outside the PICU, evaluation at hospital discharge, Final evaluation (2 months). 5. Occurrence of complications (yes or no), Measurement time: daily evaluations during admission to the PICU, Evaluations during treatment with BMT outside the PICU, Evaluation at hospital discharge, Final Evaluation (2 months). 6. PICU stay (days), Measurement time: final evaluation (2 months). 7. Hospital stay (days).Measurement time: final evaluation (2 months). 8 Re-entry within 28 days (Occurrence (yes or no), cause (infectious or non-infectious)). Measurement time: final evaluation (2 months). 9. Nutritional status (Body Mass Index). Measurement time: initial evaluation, evaluation at hospital discharge and final evaluation (2 months). 10. Thymic Area (size in mm2). Measurement time: initial and, final evaluation (2 months). 11. CD4 + count (expressed in cel / µL and in%.). Measurement time: initial and, final evaluation (2 months). 12. Quantification of Immunoglobulins (IgA, IgM, IgG). Measurement time: initial and, final evaluation (2 months). 13. Vital signs (Blood pressure, heart rate, respiratory rate, temperature, oxygen saturation). Measurement time: in evaluations during treatment with BMT, before each administrat | — |
Countries
Cuba
Contacts
Public ContactYoandra Acevedo Rodriguez
"Jose Luis Miranda" Pediatric Hospital.
Outcome results
None listed