Study Stopped
The study was prematurely interrupted for futility.
COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial
COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
2 other identifiers
interventional
184
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2006
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 9, 2012
July 1, 2012
4 years
May 31, 2006
July 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
1
EXPERIMENTAL2
NO INTERVENTIONInterventions
CPFA is a specific method for the treatment of sepsis. It consists of: 1. a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) 2. a hemofilter (polyethersulfone 1,4 m2) 3. 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.
Eligibility Criteria
You may qualify if:
- All patients admitted to the ICU in septic shock
- All patients that develop septic shock while in the ICU
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Ospedale SS. Antonio e Biagio e C. Arrigo
Alessandria, AL, 15100, Italy
Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione
Aosta, AO, 11100, Italy
Ospedali Riuniti, I Servizio Anestesia e Rianimazione
Bergamo, BG, 24128, Italy
Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione
Ponte San Pietro, BG, 24036, Italy
Ospedale Policlinico San Marco, Terapia Intensiva
Zingonia, BG, 24040, Italy
Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione
Brescia, BS, 25125, Italy
Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione
Catania, CT, 95100, Italy
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
Forlì, FC, 47100, Italy
Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
Florence, FI, 50134, Italy
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
Florence, FI, 50143, Italy
Ospedale Civile
Imperia, IM, 18100, Italy
Ospedale Civile, Servizio Anestesia e Rianimazione
Sanremo, IM, 18038, Italy
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
Lecco, LC, 23900, Italy
Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione
Matera, MT, 75100, Italy
Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso
Pisa, PI, 56100, Italy
European Hospital
Roma, RM, 00149, Italy
Ospedale San Camillo Forlanini
Roma, RM, 00152, Italy
Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione
Ivrea, TO, 10015, Italy
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Torino, TO, 10148, Italy
Related Publications (1)
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.
PMID: 24401721DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Livigni, MD
Ospedale San Giovanni Bosco, Torino, ITALY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2006
First Posted
June 1, 2006
Study Start
December 1, 2006
Primary Completion
December 1, 2010
Study Completion
July 1, 2011
Last Updated
July 9, 2012
Record last verified: 2012-07