Study Stopped
The interim analysis requested by the EDSMC shows higher mortality for the CPFA group compared to the controls, particularly in the first days of treatment.
COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2
COMPACT-2
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
1 other identifier
interventional
115
1 country
13
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
13 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
July 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 13, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2017
CompletedResults Posted
Study results publicly available
September 5, 2021
CompletedSeptember 5, 2021
March 1, 2017
4.1 years
July 6, 2012
January 15, 2021
September 2, 2021
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 (on average 30.3 days)
Secondary Outcomes (3)
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
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
15 days from randomization
Study Arms (2)
High doses CPFA
EXPERIMENTALHigh 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
NO INTERVENTIONstandard practice
Interventions
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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
Matera, Basilicate, 75100, Italy
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
Cesena, Emilia-Romagna, 47023, Italy
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
Forlì, Emilia-Romagna, 47100, Italy
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
Lecco, Lombardy, 23900, Italy
Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
Alessandria, Piedmont, 15100, Italy
Ospedale Maggiore
Chieri, Piedmont, 10023, Italy
Ospedale Santa Croce
Moncalieri, Piedmont, 10027, Italy
CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
Turin, Piedmont, 10126, Italy
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Turin, Piedmont, 10148, Italy
AOU Careggi
Florence, Tuscany, 50134, Italy
Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
Montepulciano, Tuscany, 53045, Italy
Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
Pescia, Tuscany, 51017, Italy
Ospedale Alta Val d'Elsa, Terapia Intensiva
Poggibonsi, Tuscany, 53036, Italy
Related Publications (2)
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.
PMID: 34601619DERIVEDMilla 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.
PMID: 31157074DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Guido Bertolini
- Organization
- Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Livigni, MD
Ospedale San Giovanni Bosco, Torino, ITALY
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
July 6, 2012
First Posted
July 13, 2012
Study Start
September 1, 2013
Primary Completion
October 23, 2017
Study Completion
October 23, 2017
Last Updated
September 5, 2021
Results First Posted
September 5, 2021
Record last verified: 2017-03