Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

Conditions
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Hemoperfusion, Multiorgan Failure, Sepsis

Intervention / Treatment
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* Procedure: Extracorporeal support with haemoperfusion
* Procedure: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin. | Procedure: Conventional treatment<br>* Conventional treatment<br>|
| Experimental: Extracorporeal support with haemoperfusion treatment<br>Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin. | Procedure: Extracorporeal support with haemoperfusion<br>* Use of extracorporeal support with haemoperfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressors dose | Analyze the patient's vasopressor dose during the hemoperfusion process | During hemoperfusion | 
| Vasopressors dose - Intensive Care Unit discharge | Analyze the patient's vasopressor dose prior Intensive Care Unit discharge | Prior Intensive Care Unit discharge | 
| Vasopressors dose - Hospital discharge | Analyze the patient's vasopressor dose prior Hospital discharge | Prior Hospital discharge | 
| 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 |