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

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).

Study Overview

• Status: Terminated
• Conditions: Shock, Septic
• Intervention / Treatment: Device: CPFA (Coupled Plasma Filtration Adsorption)

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • AL
    • Alessandria, AL, Italy, 15100
      • Ospedale SS. Antonio e Biagio e C. Arrigo
  • AO
    • Aosta, AO, Italy, 11100
      • Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione
  • BG
    • Bergamo, BG, Italy, 24128
      • Ospedali Riuniti, I Servizio Anestesia e Rianimazione
    • Ponte San Pietro, BG, Italy, 24036
      • Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione
    • Zingonia, BG, Italy, 24040
      • Ospedale Policlinico San Marco, Terapia Intensiva
  • BS
    • Brescia, BS, Italy, 25125
      • Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione
  • CT
    • Catania, CT, Italy, 95100
      • Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione
  • FC
    • Forlì, FC, Italy, 47100
      • Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
  • FI
    • Firenze, FI, Italy, 50134
      • Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
    • Firenze, FI, Italy, 50143
      • Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
  • IM
    • Imperia, IM, Italy, 18100
      • Ospedale Civile
    • Sanremo, IM, Italy, 18038
      • Ospedale Civile, Servizio Anestesia e Rianimazione
  • LC
    • Lecco, LC, Italy, 23900
      • Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
  • MT
    • Matera, MT, Italy, 75100
      • Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione
  • PI
    • Pisa, PI, Italy, 56100
      • Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso
  • RM
    • Roma, RM, Italy, 00149
      • European Hospital
    • Roma, RM, Italy, 00152
      • Ospedale San Camillo Forlanini
  • TO
    • Ivrea, TO, Italy, 10015
      • Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione
    • Torino, TO, Italy, 10148
      • Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: CPFA (Coupled Plasma Filtration Adsorption); CPFA is a specific method for the treatment of sepsis. It consists of: a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa); a hemofilter (polyethersulfone 1,4 m2); 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.; Other Names: Coupled Plasma Filtration Adsorption
No Intervention: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Collaborators: BELLCO S.r.l., Mirandola (MO), ITALY
• Investigators: Principal Investigator: Sergio Livigni, MD, Ospedale San Giovanni Bosco, Torino, ITALY

Publications and helpful links

General Publications

• 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.

Helpful Links

• GiViTI official web site

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 31, 2006
• First Submitted That Met QC Criteria: May 31, 2006
• First Posted (Estimate): June 1, 2006

Study Record Updates

• Last Update Posted (Estimate): July 9, 2012
• Last Update Submitted That Met QC Criteria: July 5, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Intensive Care; Shock, Septic; Adsorption; Sorption Detoxification
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 4817; ISRCTN24534559

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No