COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2
NCT ID: NCT01639664
Last Updated: 2021-09-05
Study Results
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View full resultsBasic Information
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TERMINATED
NA
115 participants
INTERVENTIONAL
2013-09-30
2017-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Control group
standard practice
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* All patients that develop septic shock while in the ICU
Exclusion Criteria
* 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
14 Years
ALL
No
Sponsors
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Bellco Srl Mirandola, Italy
INDUSTRY
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
OTHER
Responsible Party
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Principal Investigators
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Sergio Livigni, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Giovanni Bosco, Torino, ITALY
Locations
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Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
Matera, Basilicate, 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, Lombardy, Italy
Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
Alessandria, Piedmont, Italy
Ospedale Maggiore
Chieri, Piedmont, Italy
Ospedale Santa Croce
Moncalieri, Piedmont, Italy
CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
Turin, Piedmont, Italy
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Turin, Piedmont, Italy
AOU Careggi
Florence, Tuscany, Italy
Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
Montepulciano, Tuscany, Italy
Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
Pescia, Tuscany, Italy
Ospedale Alta Val d'Elsa, Terapia Intensiva
Poggibonsi, Tuscany, Italy
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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GiViTI web site
Other Identifiers
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6233
Identifier Type: -
Identifier Source: org_study_id
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