Clinical trial NCT01639664: COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shock, Septic
Keywords: septic shock
intensive care medicine
coupled plasma filtration-adsorption
Lead sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Sponsor class: OTHER
Collaborators: name: Bellco Srl Mirandola, Italy
First posted: 2012-07-13
Enrollment: 115
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Mortality
timeFrame: At the discharge from the latest hospital (on average 30.3 days)
Secondary outcomes:
measure: Mortality Within 90 Days From Randomization
timeFrame: 90 days from randomization
measure: ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
timeFrame: 30 days from randomization
measure: Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
timeFrame: 15 days from randomization
Other outcomes:
Locations:
city: Matera
country: Italy
facility: Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
state: Basilicata
city: Cesena
country: Italy
facility: Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
state: Emilia Romagna
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
state: Emilia Romagna
city: Lecco
country: Italy
facility: Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
state: Lombardia
city: Alessandria
country: Italy
facility: Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
state: Piemonte
city: Chieri
country: Italy
facility: Ospedale Maggiore
state: Piemonte
city: Moncalieri
country: Italy
facility: Ospedale Santa Croce
state: Piemonte
city: Torino
country: Italy
facility: CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
state: Piemonte
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
state: Piemonte
city: Firenze
country: Italy
facility: AOU Careggi
state: Toscana
city: Montepulciano
country: Italy
facility: Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
state: Toscana
city: Pescia
country: Italy
facility: Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
state: Toscana
city: Poggibonsi
country: Italy
facility: Ospedale Alta Val d'Elsa, Terapia Intensiva
state: Toscana
Study officials:
affiliation: Ospedale San Giovanni Bosco, Torino, ITALY
name: Sergio Livigni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garbero E, Livigni S, Ferrari F, Finazzi S, Langer M, Malacarne P, Meca MCC, Mosca S, Olivieri C, Pozzato M, Rossi C, Tavola M, Terzitta M, Viaggi B, Bertolini G; GiViTI. High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial. Intensive Care Med. 2021 Nov;47(11):1303-1311. doi: 10.1007/s00134-021-06501-3. Epub 2021 Oct 3.
citation: Milla P, Viterbo ML, Mosca S, Arpicco S. Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes. Eur J Hosp Pharm. 2018 Oct;25(e2):e83-e87. doi: 10.1136/ejhpharm-2016-001094. Epub 2017 Jan 13.