COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

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

Official Title
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COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of 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: CPFA (Coupled Plasma Filtration Adsorption)


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 18 years Pregnancy Cardiopulmonary resuscitation Cerebral coma Metastatic cancer Presence of relative or absolute contraindications to CPFA Estimated life expectancy less than 2 weeks Already included in the study 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: 18 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: 1<br> | Device: CPFA (Coupled Plasma Filtration Adsorption)<br>* CPFA is a specific method for the treatment of sepsis. It consists of: a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) a hemofilter (polyethersulfone 1,4 m2) a cartridge (contains approximately 140 ml of hydrophobic styrenic resin) The kit is lodged in the Bellco Lynda machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter.<br>* Other names: Coupled Plasma Filtration Adsorption;|
| No Intervention: 2<br> | |

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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within 90 days from randomization |  | 90 days from randomization | 
| New organ failures (assessed through SOFA score) |  | Within ICU stay | 
| Days not spent in the ICU during the first 30 days from randomization |  | 30 days from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care, Shock, Septic, Adsorption, Sorption Detoxification