Biomodulina T in pediatric septic shock. Exploratory study
Not Applicable
- Conditions
- Septic shockShock, SepticSepsisShockPathologic ProcessesSystemic Inflammatory Response SyndromePediatrics
- Registration Number
- RPCEC00000327
- Lead Sponsor
- Centro Nacional de Biopreparados (BioCen)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 28-day mortality (Depending on the condition of the patient, alive or deceased). Measurement time: final evaluation (2 months).
- Secondary Outcome Measures
Name Time Method