Shock, not elsewhere classified Cardiovascular Diseases
Conditions
Interventions
This is a single-center, prospective, randomized, double-blind, placebo-controlled study conducted in adult patients diagnosed with circulatory shock. A total of 40 participants will be included and r
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients of both sexes; aged 18 years or older; diagnosis of circulatory shock defined by the need for vasopressors to maintain mean arterial pressure above 65 mmHg and serum lactate greater than 2 mg/dL; signed informed consent provided by the legal representative
Exclusion criteria
Exclusion criteria: Neoplastic disease; advanced liver failure; stage IV renal failure or receiving renal replacement therapy; type 1 diabetes mellitus; post–cardiac arrest; patients receiving exclusive palliative care; use of oral anticoagulation; pregnancy or possibility of pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find reduced endothelial glycocalyx injury in the intervention group (doxycycline) compared to the control group (placebo), verified through serum and urinary measurements of specific biomarkers (Syndecan-1, Chondroitin sulfate, Hyaluronic acid, urinary glycosaminoglycans) using commercial Enzyme-Linked Immunosorbent Assay (ELISA) kits and the colorimetric Dimethylmethylene Blue Assay (DMMB), in addition to non-invasive assessment of glycocalyx thickness in the sublingual microcirculation with the GlycoCheck™ system. A significant difference will be considered when a reduction in serum and urinary biomarker levels and an increase in glycocalyx thickness in the sublingual microcirculation are observed between D0, D3, and D7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the progression of organ dysfunction, verified by the Sequential Organ Failure Assessment (SOFA) score, comparing intervention and control groups at D0, D3, and D7;To evaluate disseminated intravascular coagulation activation, verified by the DIC score from the International Society on Thrombosis and Haemostasis, comparing intervention and control groups at D0, D3, and D7;To evaluate the occurrence of acute kidney injury, verified by serum cystatin-C measurement using the Enzyme-Linked Immunosorbent Assay (ELISA) method, comparing intervention and control groups at D0, D3, and D7;To evaluate metalloproteinase activity as a marker of the inhibitory action of doxycycline, verified by Enzyme-Linked Immunosorbent Assay (ELISA) technique using commercially available kits, comparing intervention and control groups at D0, D3, and D7;To evaluate systemic inflammatory response, verified by serum measurement of inflammatory cytokines TNF-a and IL-6 using the Enzyme-Linked Immunosorbent Assay (ELISA) method, comparing intervention and control groups at D0, D3, and D7;To evaluate lactate clearance, verified by serial serum lactate measurement at D0, D3, and D7, comparing intervention and control groups | — |
Countries
BR
Contacts
Public ContactErick Porto
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed