Clinical trial NCT00332371: COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial
Official title: COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shock, Septic
Keywords: Intensive Care
Shock, Septic
Adsorption
Sorption Detoxification
Lead sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Sponsor class: OTHER
Collaborators: name: Bellco Srl Mirandola, Italy
First posted: 2006-06-01
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: 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 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: 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.

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 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

Primary outcomes:
measure: 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)
timeFrame: At the discharge from the latest hospital
Secondary outcomes:
measure: Mortality within 90 days from randomization
timeFrame: 90 days from randomization
measure: New organ failures (assessed through SOFA score)
timeFrame: Within ICU stay
measure: Days not spent in the ICU during the first 30 days from randomization
timeFrame: 30 days from randomization
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale SS. Antonio e Biagio e C. Arrigo
state: AL
city: Aosta
country: Italy
facility: Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione
state: AO
city: Bergamo
country: Italy
facility: Ospedali Riuniti, I Servizio Anestesia e Rianimazione
state: BG
city: Ponte San Pietro
country: Italy
facility: Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione
state: BG
city: Zingonia
country: Italy
facility: Ospedale Policlinico San Marco, Terapia Intensiva
state: BG
city: Brescia
country: Italy
facility: Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione
state: BS
city: Catania
country: Italy
facility: Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione
state: CT
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
state: FC
city: Firenze
country: Italy
facility: Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
state: FI
city: Firenze
country: Italy
facility: Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
state: FI
city: Imperia
country: Italy
facility: Ospedale Civile
state: IM
city: Sanremo
country: Italy
facility: Ospedale Civile, Servizio Anestesia e Rianimazione
state: IM
city: Lecco
country: Italy
facility: Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
state: LC
city: Matera
country: Italy
facility: Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione
state: MT
city: Pisa
country: Italy
facility: Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso
state: PI
city: Roma
country: Italy
facility: European Hospital
state: RM
city: Roma
country: Italy
facility: Ospedale San Camillo Forlanini
state: RM
city: Ivrea
country: Italy
facility: Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione
state: TO
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
state: TO
Study officials:
affiliation: Ospedale San Giovanni Bosco, Torino, ITALY
name: Sergio Livigni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.