Sepsis Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with multiorgan dysfunction syndrome by septic origin.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions: - Sepsis of abdominal origin with controlled infectious focus. - Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy. - Dysfunction of two or more organs with SOFA = 9 (5). - Blood lactate = 2 mmol / L. - Procalcitonin (PCT)> 10 ng / mL. - CRP> 100 mg / L. - IL-6> 2000 pg / ml. Exclusion Criteria: - Age under 18 years or over 80 years. - Pregnancy or breastfeeding. - Terminally ill patients or with a life expectancy of less than 48 hours. - Thrombocytopenia <60,000 / mm3. - Pancytopenia. - Severe coagulopathy with high risk of bleeding. - Inclusion in another research protocol. - In case of re-entry during the study period, only the first admission will be included. - Use of another haemoperfusion device. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vasopressors dose | Analyze the patient's vasopressor dose during the hemoperfusion process | During hemoperfusion | |
Primary | Vasopressors dose - Intensive Care Unit discharge | Analyze the patient's vasopressor dose prior Intensive Care Unit discharge | Prior Intensive Care Unit discharge | |
Primary | Vasopressors dose - Hospital discharge | Analyze the patient's vasopressor dose prior Hospital discharge | Prior Hospital discharge | |
Primary | Vasopressors dose - 90 days post-Intensive Care Unit discharge | Analyze the patient's vasopressor dose 90 days post-Intensive Care Unit discharge | 90 days post-Intensive Care Unit discharge |
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