COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2
- Conditions
- Shock, Septic
- Interventions
- Device: High doses CPFA
- Registration Number
- NCT01639664
- Lead Sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 115
- All patients admitted to the ICU in septic shock
- All patients that develop septic shock while in the ICU
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High doses CPFA High doses CPFA 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.
- Primary Outcome Measures
Name Time Method Hospital Mortality At the discharge from the latest hospital (on average 30.3 days) For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.
- Secondary Outcome Measures
Name Time Method Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization 15 days from randomization 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
Trial Locations
- Locations (13)
Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
🇮🇹Matera, Basilicata, Italy
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
🇮🇹Cesena, Emilia Romagna, Italy
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
🇮🇹Forlì, Emilia Romagna, Italy
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
🇮🇹Lecco, Lombardia, Italy
Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
🇮🇹Alessandria, Piemonte, Italy
Ospedale Maggiore
🇮🇹Chieri, Piemonte, Italy
CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
🇮🇹Torino, Piemonte, Italy
Ospedale Santa Croce
🇮🇹Moncalieri, Piemonte, Italy
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
🇮🇹Torino, Piemonte, Italy
Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
🇮🇹Montepulciano, Toscana, Italy
AOU Careggi
🇮🇹Firenze, Toscana, Italy
Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
🇮🇹Pescia, Toscana, Italy
Ospedale Alta Val d'Elsa, Terapia Intensiva
🇮🇹Poggibonsi, Toscana, Italy