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COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2 (COMPACT-2)

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ClinicalTrials.gov Identifier: NCT01639664
Recruitment Status : Recruiting
First Posted : July 13, 2012
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
BELLCO Srl Mirandola (MO) ITALY
Information provided by (Responsible Party):
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

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).

Condition or disease Intervention/treatment Phase
Shock, Septic Device: High doses CPFA Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: 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.
Device: 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.

No Intervention: Control group
standard practice



Primary Outcome Measures :
  1. Hospital mortality [ Time Frame: At the discharge from the latest hospital (on average 30,3 days) ]
    For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.


Secondary Outcome Measures :
  1. Mortality within 90 days from randomization [ Time Frame: 90 days from randomization ]
  2. ICU LOS reduction measured as days not spent in the ICU during the first 30 days from randomization [ Time Frame: 30 days from randomization ]
  3. Septic shock resolution measured as number of days free of vasoactive drugs from randomization [ Time Frame: 15 days from randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639664


Contacts
Contact: Guido Bertolini, MD +390354535313 guido.bertolini@marionegri.it
Contact: Luana Nava +390354535313 luana.nava@marionegri.it

Locations
Italy
Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione Recruiting
Matera, Basilicata, Italy, 75100
Contact: Massimo Romito, MD         
Principal Investigator: Massimo Romito, MD         
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva Recruiting
Cesena, Emilia Romagna, Italy, 47023
Contact: Manlio Meca, MD         
Principal Investigator: Manlio Meca, MD         
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione Recruiting
Forlì, Emilia Romagna, Italy, 47100
Contact: Marina Terzitta, MD         
Principal Investigator: Marina Terzitta, MD         
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1 Recruiting
Lecco, Lombardia, Italy, 23900
Contact: Giuseppe Nattino, MD         
Principal Investigator: Giuseppe Nattino, MD         
Policlinico San Marco, Terapia Intensiva Not yet recruiting
Zingonia (BG), Lombardia, Italy, 24040
Contact: Bruno Balicco, MD         
Principal Investigator: Bruno Balicco, MD         
Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica Recruiting
Alessandria, Piemonte, Italy, 15100
Contact: Luciana Ventura, MD         
Principal Investigator: Luciana Ventura, MD         
Ospedale Maggiore Recruiting
Chieri, Piemonte, Italy, 10023
Contact: Stefano Meinardi, MD         
Principal Investigator: Stefano Meinardi, MD         
Ospedale Santa Croce Recruiting
Moncalieri, Piemonte, Italy, 10027
Contact: Gilberto Fiore, MD         
Principal Investigator: Gilberto Fiore, MD         
CTO Maria Adelaide, I Servizio Anestesia e Rianimazione Recruiting
Torino, Piemonte, Italy, 10126
Contact: Luisa Tedeschi, MD         
Principal Investigator: Luisa Tedeschi, MD         
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA Recruiting
Torino, Piemonte, Italy, 10148
Contact: Sergio Livigni, MD         
Principal Investigator: Sergio Livigni, MD         
Ospedale Francesco Ferrari, Anestesia, Rianimazione e Terapia Antalgica Not yet recruiting
Casarano, Puglia, Italy, 73042
Contact: Giancarlo Negro, MD         
Principal Investigator: Giancarlo Negro, MD         
Ospedale Vittorio Emanuele, Rianimazione Not yet recruiting
Catania, Sicilia, Italy, 95100
Contact: Giacomo Castiglione, MD         
Principal Investigator: Giacomo Castiglione, MD         
ARNAS Civico e Benfratelli, II Servizio Anestesia e Rianimazione Not yet recruiting
Palermo, Sicilia, Italy, 90127
Contact: Ettore Lo Bianco, MD         
Principal Investigator: Ettore Lo Bianco, MD         
Ospedale Santa Maria Annunziata, U.O Servizio Anestesia e Rianimazione Recruiting
Firenze, Toscana, Italy, 50011
Contact: Francesca Frigieri, MD         
Principal Investigator: Francesca Frigieri, MD         
Ospedale Santa Maria Nuova, Anestesia e Rianimazione Recruiting
Firenze, Toscana, Italy, 50122
Contact: Massimo Barattini, MD         
Principal Investigator: Massimo Barattini, MD         
AOU Careggi - Villa Monna Tessa Not yet recruiting
Firenze, Toscana, Italy, 50134
Contact: Alberto Sardu, MD         
Principal Investigator: Alberto Sardu, MD         
AOU Careggi Recruiting
Firenze, Toscana, Italy, 50134
Contact: Bruno Viaggi, MD         
Principal Investigator: Bruno Viaggi, MD         
Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione Recruiting
Montepulciano, Toscana, Italy, 53045
Contact: Salvatore Criscuolo, MD         
Principal Investigator: Salvatore Criscuolo, MD         
Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione Recruiting
Pescia, Toscana, Italy, 51017
Contact: Valentina Gori, MD         
Principal Investigator: Valentina Gori, MD         
Ospedlae di S. Chiara Not yet recruiting
Pisa, Toscana, Italy, 56100
Contact: Paolo Malacarne, MD         
Principal Investigator: Paolo Malacarne, MD         
Ospedale Alta Val d'Elsa, Terapia Intensiva Recruiting
Poggibonsi, Toscana, Italy, 53036
Contact: Andrea Veneziani, MD         
Principal Investigator: Andrea Veneziani, MD         
Sponsors and Collaborators
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
BELLCO Srl Mirandola (MO) ITALY
Investigators
Principal Investigator: Sergio Livigni, MD Ospedale San Giovanni Bosco, Torino, ITALY

Additional Information:
Responsible Party: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
ClinicalTrials.gov Identifier: NCT01639664     History of Changes
Other Study ID Numbers: 6233
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock