septic shock
Conditions
Interventions
This is a prospective, randomized (1:1), open study for the multi-professional clinical team of the Intensive Care Units and blinded for the analysis of clinical and pharmacodynamic outcomes. A total
D27.505.519.389.739
Sponsors
Escola Paulista de Medicina, Universidade Federal de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Male patients diagnosed with septic shock for less than 24 hours; signing of free and informed consent form
Exclusion criteria
Exclusion criteria: Female patients (women) because women's hormones can alter the effects of olaparib; patients unable to use medication by mouth or by tube; patients with AIDS; patients using immunosuppressive therapy, that is, which compromises the body's defenses; patients using corticosteroids; patients with cancer or undergoing chemotherapy; chemotherapy performed up to 30 days; patients who had cardiac arrest; patients with recent acute infarction or problems with the coronary artery, the artery that supplies the heart; liver disease, such as liver cirrhosis; very severe patients, with the prospect of death within 24 hours; palliative or end-of-life care; patients using treatments that may have their effects altered or alter the effects of olaparib (examples: itraconazole, fluconazole, verapamil, rifampicin, phenytoin, carbamazepine, phenobarbital and modafinil; Saint John's herb)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of olaparib in patients with septic shock, through clinical evaluation and laboratory tests including routine hematologic tests, liver enzymes, renal function, muscle damage (CPK levels) and metabolic changes (lactate levels). ;Evaluate the concentration of olaparib in the blood of the first 5 patients selected to receive the drug (intervention group), to verify if the drug is reaching the desired concentration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes will be evaluated by the patient's evolution, evaluating the improvement of organ function (for this we will use a scale called SOFA (Sequential [Sepsis-related] Organ Failure Assessment) which means sequential assessment of organ failure related to sepsis ); need for vasopressor drugs to restore blood pressure; days in the intensive care unit (ICU); survival or death in the ICU, hospital, 60 and 90 days after hospital discharge. | — |
Countries
Brazil
Contacts
Public ContactReinaldo Salomão
Escola Paulista de Medicina, Universidade Federal de São Paulo
Outcome results
None listed