COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2

Study Overview
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Brief Summary
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The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).

Detailed Description
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Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of high doses CPFA in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit. Secondary objectives are the resolution of septic shock and the reduction of ICU LOS (length of stay).

Official Title
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COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of High Doses CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU

Conditions
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Shock, Septic

Intervention / Treatment
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* Device: High doses CPFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the ICU in septic shock All patients that develop septic shock while in the ICU Exclusion Criteria: Age less than 14 years Pregnancy Estimated life expectancy (due to comorbidities) less than 90 days Presence of relative or absolute contraindications to CPFA Admission from an other ICU where the patient remained for more than 24 hours Absence of informed consent

Ages Eligible for Study
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Minimum Age: 14 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High doses CPFA<br>High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization. | Device: High doses CPFA<br>* High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.<br>|
| No Intervention: Control group<br>standard practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed. | At the discharge from the latest hospital (on average 30.3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Within 90 Days From Randomization |  | 90 days from randomization | 
| ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization |  | 30 days from randomization | 
| Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization |  | 15 days from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, intensive care medicine, coupled plasma filtration-adsorption